<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03307785</url>
  </required_header>
  <id_info>
    <org_study_id>213351</org_study_id>
    <secondary_id>3000-01-002</secondary_id>
    <nct_id>NCT03307785</nct_id>
  </id_info>
  <brief_title>Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042</brief_title>
  <official_title>Phase 1b Dose-Finding Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 in Patients With Advanced or Metastatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tesaro, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tesaro, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Part A: To test the safety and tolerability of combination therapy with Niraparib and TSR-042&#xD;
      and to establish a safe dose that will be used in a Phase 2 study.&#xD;
&#xD;
      Part B: To test the safety and tolerability of combination therapy with&#xD;
      Carboplatin-Paclitaxel and TSR-042 and to establish a safe dose that will be used in a Phase&#xD;
      2 study.&#xD;
&#xD;
      Part C: To test the safety and tolerability of combination therapy with Niraparib, TSR-042&#xD;
      and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study.&#xD;
&#xD;
      Part D: To test the safety and tolerability of combination therapy with&#xD;
      Carboplatin-Paclitaxel, TSR-042 and Bevacizumab and to establish a safe dose that will be&#xD;
      used in a Phase 2 study.&#xD;
&#xD;
      Part E: To test the safety and tolerability of combination therapy with&#xD;
      Carboplatin-Pemetrexed and TSR-042 and to establish a safe dose that will be used in a Phase&#xD;
      2 study.&#xD;
&#xD;
      Part F: To test the safety and tolerability of combination therapy with&#xD;
      Carboplatin-Pemetrexed, TSR-022 and TSR-042 and to establish a safe dose that will be used in&#xD;
      a Phase 2 study.&#xD;
&#xD;
      Part G: To test the safety and tolerability of combination therapy with&#xD;
      Carboplatin-nab-Paclitaxel, TSR-042 and to establish a safe dose that will be used in a Phase&#xD;
      2 study.&#xD;
&#xD;
      Part H: To test the safety and tolerability of combination therapy with&#xD;
      Carboplatin-nab-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be&#xD;
      used in a Phase 2 study.&#xD;
&#xD;
      Part I: To test the safety and tolerability of combination therapy with&#xD;
      Carboplatin-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in&#xD;
      a Phase 2 study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Anticipated">April 22, 2024</completion_date>
  <primary_completion_date type="Actual">February 26, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part A: Number of Participants With Dose-limiting Toxicity (DLT)</measure>
    <time_frame>21 days</time_frame>
    <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B: Number of Participants With DLT</measure>
    <time_frame>21 days</time_frame>
    <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part C: Number of Participants With DLT</measure>
    <time_frame>21 days</time_frame>
    <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part D: Number of Participants With DLT</measure>
    <time_frame>21 days</time_frame>
    <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part E: Number of Participants With DLT</measure>
    <time_frame>21 days</time_frame>
    <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part F: Number of Participants With DLT</measure>
    <time_frame>21 days</time_frame>
    <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part G: Number of Participants With DLT</measure>
    <time_frame>21 days</time_frame>
    <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part H: Number of Participants With DLT</measure>
    <time_frame>21 days</time_frame>
    <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Number of Participants With DLT</measure>
    <time_frame>21 days</time_frame>
    <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</measure>
    <time_frame>Up to 22.5 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</measure>
    <time_frame>Up to 9.5 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</measure>
    <time_frame>Up to 4.4 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</measure>
    <time_frame>Up to 3.5 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part A: Objective Response Rate</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Objective Response Rate</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Objective Response Rate</measure>
    <time_frame>Up to 22.5 months</time_frame>
    <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Objective Response Rate</measure>
    <time_frame>Up to 9.5 months</time_frame>
    <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Objective Response Rate</measure>
    <time_frame>Up to 4.4 months</time_frame>
    <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Objective Response Rate</measure>
    <time_frame>Up to 3.5 months</time_frame>
    <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Objective Response Rate</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Objective Response Rate</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Objective Response Rate</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Duration of Response</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Duration of Response</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause. Data is not reported as participants response is still ongoing at the time of primary analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Duration of Response</measure>
    <time_frame>Up to 22.5 months</time_frame>
    <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause. Data is not reported as participants response is still ongoing at the time of primary analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Duration of Response</measure>
    <time_frame>Up to 9.5 months</time_frame>
    <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause. Data is not reported as participants response is still ongoing at the time of primary analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Duration of Response</measure>
    <time_frame>Up to 4.4 months</time_frame>
    <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Duration of Response</measure>
    <time_frame>Up to 3.5 months</time_frame>
    <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Duration of Response</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Duration of Response</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Duration of Response</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Disease Control Rate</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Disease Control Rate</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Disease Control Rate</measure>
    <time_frame>Up to 22.5 months</time_frame>
    <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Disease Control Rate</measure>
    <time_frame>Up to 9.5 months</time_frame>
    <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Disease Control Rate</measure>
    <time_frame>Up to 4.4 months</time_frame>
    <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Disease Control Rate</measure>
    <time_frame>Up to 3.5 months</time_frame>
    <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Disease Control Rate</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Disease Control Rate</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Disease Control Rate</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Progression-free Survival</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Progression-free Survival</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Progression-free Survival</measure>
    <time_frame>Up to 22.5 months</time_frame>
    <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Progression-free Survival</measure>
    <time_frame>Up to 9.5 months</time_frame>
    <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Progression-free Survival</measure>
    <time_frame>Up to 4.4 months</time_frame>
    <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Progression-free Survival</measure>
    <time_frame>Up to 3.5 months</time_frame>
    <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Progression-free Survival</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Progression-free Survival</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Progression-free Survival</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Number of Participants With Positive Anti-TSR-042 Antibodies</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Number of Participants With Positive Anti-TSR-042 Antibodies</measure>
    <time_frame>Up to 28.5 months</time_frame>
    <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Number of Participants With Positive Anti-TSR-042 Antibodies</measure>
    <time_frame>Up to 22.5 months</time_frame>
    <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Number of Participants With Positive Anti-TSR-042 Antibodies</measure>
    <time_frame>Up to 9.5 months</time_frame>
    <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Number of Participants With Positive Anti-TSR-042 Antibodies</measure>
    <time_frame>Up to 4.4 months</time_frame>
    <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Number of Participants With Positive Anti-TSR-042 Antibodies</measure>
    <time_frame>Up to 3.5 months</time_frame>
    <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Number of Participants With Positive Anti-TSR-022 Antibodies</measure>
    <time_frame>Up to 3.5 months</time_frame>
    <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Number of Participants With Positive Anti-TSR-042 Antibodies</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Number of Participants With Positive Anti-TSR-042 Antibodies</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Number of Participants With Positive Anti-TSR-022 Antibodies</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Number of Participants With Positive Anti-TSR-042 Antibodies</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Number of Participants With Positive Anti-TSR-022 Antibodies</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib</measure>
    <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: AUC(0-t) of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: AUC0-t of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: AUC0-t of Niraparib</measure>
    <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: AUC0-t of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: AUC0-t of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: AUC0-t of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: AUC0-t of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: AUC0-t of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: AUC0-t of TSR-042</measure>
    <time_frame>Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: AUC0-t of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: AUC0-t of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: AUC0-t of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: AUC0-t of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib</measure>
    <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: AUC(0-infinity) of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: AUC(0-infinity) of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: AUC(0-infinity) of Niraparib</measure>
    <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: AUC(0-infinity) of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: AUC(0-infinity) of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: AUC(0-infinity) of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: AUC(0-infinity) of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: AUC(0-infinity) of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: AUC(0-infinity) of TSR-042</measure>
    <time_frame>Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: AUC(0-infinity) of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: AUC(0-infinity) of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: AUC(0-infinity) of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: AUC(0-infinity) of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib</measure>
    <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Ctau of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Ctau of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Ctau of Niraparib</measure>
    <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Ctau of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Ctau of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Ctau of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Ctau of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Ctau of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Ctau of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Ctau of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Ctau of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Ctau of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Ctau of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Maximum Observed Plasma (Cmax) of Niraparib</measure>
    <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Cmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Cmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Cmax of Niraparib</measure>
    <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Cmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Cmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Cmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Cmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Cmax of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Cmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Cmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Cmax of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Cmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Cmax of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Clearance After Oral Administration (CL/F) of Niraparib</measure>
    <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Clearance After Intravenous Administration (CL) of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: CL of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: CL/F of Niraparib</measure>
    <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: CL of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: CL of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: CL of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: CL of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: CL of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: CL of TSR-042</measure>
    <time_frame>Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: CL of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: CL of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: CL of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: CL of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib</measure>
    <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Vz of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Vz/F of Niraparib</measure>
    <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Vz of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Vz of TSR-042</measure>
    <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Vz of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Vz of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Vz of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Vz of TSR-042</measure>
    <time_frame>Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Vz of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Vz of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Vz of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Vz of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: AUC at Steady State (AUCss) of Niraparib</measure>
    <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: AUCss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: AUCss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: AUCss of Niraparib</measure>
    <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: AUCss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: AUCss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: AUCss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: AUCss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: AUCss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: AUCss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: AUCss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: AUCss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: AUCss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: AUCss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Ctau at Steady State (Ctau,ss) of Niraparib</measure>
    <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Ctau,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Ctau,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Ctau,ss of Niraparib</measure>
    <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Ctau,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Ctau,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Ctau,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Ctau,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Ctau,ss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Ctau,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Ctau,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Ctau,ss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Ctau,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Ctau,ss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Cmax at Steady State (Cmax,ss) of Niraparib</measure>
    <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Cmax,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Cmax,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Cmax,ss of Niraparib</measure>
    <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Cmax,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Cmax,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Cmax,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Cmax,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Cmax,ss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Cmax,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Cmax,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Cmax,ss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Cmax,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Cmax,ss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib</measure>
    <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Tmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Tmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Tmax of Niraparib</measure>
    <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Tmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Tmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Tmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Tmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Tmax of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Tmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Tmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Tmax of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Tmax of TSR-042</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Tmax of TSR-022</measure>
    <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Tmax at Steady State (Tmax,ss) of Niraparib</measure>
    <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Tmax,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Tmax,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Tmax,ss of Niraparib</measure>
    <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Tmax,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Tmax,ss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Tmax,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Tmax,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Tmax,ss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Tmax,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Tmax,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Tmax,ss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Tmax,ss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Tmax,ss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Vss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part C: Vss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D: Vss of TSR-042</measure>
    <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part E: Vss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Vss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part F: Vss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part G: Vss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Vss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part H: Vss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Vss of TSR-042</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part I: Vss of TSR-022</measure>
    <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
    <description>Blood samples were planned to be collected at indicated time points.</description>
  </secondary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Neoplasms</condition>
  <condition>Metastatic Cancer</condition>
  <condition>Advanced Cancer</condition>
  <condition>Solid Tumor</condition>
  <condition>Non Small Cell Lung Cancer Metastatic</condition>
  <condition>Non Small Cell Lung Cancer Stage IIIB</condition>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Part A: TSR-042 and niraparib 200 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: TSR-042 and niraparib 300 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: TSR-042 and carboplatin-paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C: TSR-042, niraparib 200 mg QD and bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part C: TSR-042, niraparib 300 mg QD and bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part D: TSR-042, carboplatin-paclitaxel and bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part E: TSR-042 and carboplatin-pemetrexed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for 6 cycles (each cycle is 21 days).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part F: TSR-042, TSR-022, and carboplatin-pemetrexed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for 5 cycles (each cycle is 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part G: TSR-042 and carboplatin-nab-paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part I: TSR-042, TSR-022, and carboplatin-paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niraparib</intervention_name>
    <description>Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.</description>
    <arm_group_label>Part A: TSR-042 and niraparib 200 mg QD</arm_group_label>
    <arm_group_label>Part A: TSR-042 and niraparib 300 mg QD</arm_group_label>
    <arm_group_label>Part C: TSR-042, niraparib 200 mg QD and bevacizumab</arm_group_label>
    <arm_group_label>Part C: TSR-042, niraparib 300 mg QD and bevacizumab</arm_group_label>
    <other_name>Zejula</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TSR-042</intervention_name>
    <description>TSR-042 is a humanized monoclonal antibody that binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).</description>
    <arm_group_label>Part A: TSR-042 and niraparib 200 mg QD</arm_group_label>
    <arm_group_label>Part A: TSR-042 and niraparib 300 mg QD</arm_group_label>
    <arm_group_label>Part B: TSR-042 and carboplatin-paclitaxel</arm_group_label>
    <arm_group_label>Part C: TSR-042, niraparib 200 mg QD and bevacizumab</arm_group_label>
    <arm_group_label>Part C: TSR-042, niraparib 300 mg QD and bevacizumab</arm_group_label>
    <arm_group_label>Part D: TSR-042, carboplatin-paclitaxel and bevacizumab</arm_group_label>
    <arm_group_label>Part E: TSR-042 and carboplatin-pemetrexed</arm_group_label>
    <arm_group_label>Part F: TSR-042, TSR-022, and carboplatin-pemetrexed</arm_group_label>
    <arm_group_label>Part G: TSR-042 and carboplatin-nab-paclitaxel</arm_group_label>
    <arm_group_label>Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel</arm_group_label>
    <arm_group_label>Part I: TSR-042, TSR-022, and carboplatin-paclitaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin-Paclitaxel</intervention_name>
    <description>Carboplatin in combination with paclitaxel is a chemotherapy treatment that has been shown to be efficacious against a variety of different tumor types, including non-small cell lung cancer [NSCLC], ovarian cancer, endometrial cancer, and head and neck cancer.</description>
    <arm_group_label>Part B: TSR-042 and carboplatin-paclitaxel</arm_group_label>
    <arm_group_label>Part D: TSR-042, carboplatin-paclitaxel and bevacizumab</arm_group_label>
    <arm_group_label>Part I: TSR-042, TSR-022, and carboplatin-paclitaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Bevacizumab is a chemotherapy treatment that has been shown to be efficacious against a variety of different cancer types, including colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. Bevacizumab is in the angiogenesis inhibitor and monoclonal antibody families of medication. It works by slowing the growth of new blood vessels.</description>
    <arm_group_label>Part C: TSR-042, niraparib 200 mg QD and bevacizumab</arm_group_label>
    <arm_group_label>Part C: TSR-042, niraparib 300 mg QD and bevacizumab</arm_group_label>
    <arm_group_label>Part D: TSR-042, carboplatin-paclitaxel and bevacizumab</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TSR-022</intervention_name>
    <description>TSR-022 is a monoclonal antibody against TIM-3 (also called HAVCR2), an immune checkpoint receptor. Immune checkpoint proteins are molecules that help to regulate the immune system so it does not mistakenly attack healthy cells. However, they can also keep immune cells from recognizing and killing cancer cells.&#xD;
TIM-3 is found on the surface of certain T-cells, including tumor-infiltrating T-cells, that have left the bloodstream and migrated into the tumor environment. By binding to and blocking TIM-3, TRS-022 allows for T-cells to become activated so as to enhance T-cell-mediated attacks on tumors. These attacks reduce their growth.</description>
    <arm_group_label>Part F: TSR-042, TSR-022, and carboplatin-pemetrexed</arm_group_label>
    <arm_group_label>Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel</arm_group_label>
    <arm_group_label>Part I: TSR-042, TSR-022, and carboplatin-paclitaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin-Pemetrexed</intervention_name>
    <description>Pemetrexed and platinum therapy in combination with pembrolizumab (anti-PD-1 antibody) has proven to be efficacious in a first line setting for nonsquamous NSCLC patients</description>
    <arm_group_label>Part E: TSR-042 and carboplatin-pemetrexed</arm_group_label>
    <arm_group_label>Part F: TSR-042, TSR-022, and carboplatin-pemetrexed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin-Nab-Paclitaxel</intervention_name>
    <description>Nab-paclitaxel is a formulation of paclitaxel that is indicated for locally advanced or metastatic NSCLC, as first-line treatment in combination with carboplatin in patients who are not candidates for curative surgery or radiation therapy. Nab-paclitaxel has shown increased ORR and time to progression in metastatic breast cancer compared with solvent-based paclitaxel and has shown antitumor activity and improved ORR compared with solvent-based paclitaxel as first-line therapy in patients with NSCLC.</description>
    <arm_group_label>Part G: TSR-042 and carboplatin-nab-paclitaxel</arm_group_label>
    <arm_group_label>Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has histologically or cytologically proven advanced (unresectable) or&#xD;
             metastatic cancer as outlined below according to study part and disease type:&#xD;
&#xD;
          -  Part A: Patients with previously treated advanced or metastatic cancer. Patient may&#xD;
             have received no more than 4 lines of treatment for advanced or metastatic cancer.&#xD;
             Hormonal treatment will not be considered a prior line of treatment.&#xD;
&#xD;
          -  Part B: Patients with advanced or metastatic cancer for which treatment with&#xD;
             carboplatin-paclitaxel is considered appropriate therapy. Patient may have received no&#xD;
             more than 1 prior line of chemotherapy in the metastatic setting. Hormonal treatment&#xD;
             will not be considered a prior line of treatment.&#xD;
&#xD;
          -  Part C: Patients with previously treated advanced or metastatic cancer. Patient may&#xD;
             have received no more than 4 lines of treatment for advanced or metastatic cancer.&#xD;
             Hormonal treatment will not be considered a prior line of treatment.&#xD;
&#xD;
          -  Part D: Patients in whom carboplatin-paclitaxel and bevacizumab is considered&#xD;
             appropriate therapy. Patient may have received no more than 1 prior line of&#xD;
             chemotherapy in the metastatic setting. Hormonal treatment will not be considered a&#xD;
             prior line of treatment.&#xD;
&#xD;
          -  Part E and F: Patients who have not received prior systemic therapy, including&#xD;
             targeted therapy and biologic agents, for their advanced or metastatic (Stage ≥ IIIB&#xD;
             or IV) Non-Squamous NSCLC. Patients who have received neoadjuvant or adjuvant therapy&#xD;
             are eligible as long as development of advanced or metastatic disease occurred at&#xD;
             least 12 months after completion of neoadjuvant or adjuvant therapy.&#xD;
&#xD;
          -  Part G, H, and I: Patients who have not received prior systemic therapy, including&#xD;
             targeted therapy and biologic agents, for their advanced or metastatic (Stage ≥ IIIB&#xD;
             or IV) NSCLC. Patients who have received neoadjuvant or adjuvant therapy are eligible&#xD;
             as long as development of advanced or metastatic disease occurred at least 12 months&#xD;
             after completion of neoadjuvant or adjuvant therapy.&#xD;
&#xD;
          -  Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.&#xD;
&#xD;
          -  Patient has adequate organ function.&#xD;
&#xD;
          -  Female patient has a negative serum pregnancy test within 72 hours prior to taking&#xD;
             study treatment if of childbearing potential and agrees to abstain from activities&#xD;
             that could result in pregnancy from screening through 180 days after the last dose of&#xD;
             study treatment, or is of non-childbearing potential.&#xD;
&#xD;
          -  Male patient agrees to use an adequate method of contraception and not donate sperm&#xD;
             starting with the first dose of study treatment through 90 days after the last dose of&#xD;
             study treatment. Note: Abstinence is acceptable if this is the established and&#xD;
             preferred contraception for the patient.&#xD;
&#xD;
          -  Patient has measurable lesions by RECIST v1.1.&#xD;
&#xD;
        For Part A and C, in addition to the general inclusion criteria, patients must also meet&#xD;
        the following additional criterion to be considered eligible to participate in this study:&#xD;
&#xD;
          -  Patient is able to take oral medications.&#xD;
&#xD;
          -  For patients to be eligible for any parts of the study using niraparib 300 mg as a&#xD;
             starting dose, a screening actual body weight ≥ 77 kg and screening platelet count ≥&#xD;
             150,000 u/L is necessary.&#xD;
&#xD;
        Exclusion Criteria: (Patients will not be eligible for the study entry if any of the&#xD;
        following criteria are met)&#xD;
&#xD;
          -  Patient has known active central nervous system metastases, carcinomatous meningitis,&#xD;
             or both.&#xD;
&#xD;
          -  Patient has a known additional malignancy that progressed or required active treatment&#xD;
             within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous&#xD;
             cell carcinoma of the skin that has undergone potentially curative therapy, or in situ&#xD;
             cervical cancer.&#xD;
&#xD;
          -  Patient is considered a poor medical risk due to a serious, uncontrolled medical&#xD;
             disorder, nonmalignant systemic disease, or active infection that requires systemic&#xD;
             therapy.&#xD;
&#xD;
          -  Patient has a condition (such as transfusion-dependent anemia or thrombocytopenia),&#xD;
             therapy, or laboratory abnormality that might confound the study results or interfere&#xD;
             with the patient's participation&#xD;
&#xD;
          -  Patient is pregnant or expecting to conceive children within the projected duration of&#xD;
             the study, starting with the screening visit through 180 days after the last dose of&#xD;
             study treatment.&#xD;
&#xD;
        Note: No data are available regarding the presence of niraparib or its metabolites in human&#xD;
        milk, or on its effects on the breastfed infant or milk production. Because of the&#xD;
        potential for serious adverse reactions in breastfed infants from niraparib, female&#xD;
        patients should not breastfeed during treatment with niraparib and for 1 month after&#xD;
        receiving the final dose.&#xD;
&#xD;
          -  Patient has a known history of human immunodeficiency virus (type 1 or 2 antibodies).&#xD;
&#xD;
          -  Patient has known active hepatitis B or hepatitis C.&#xD;
&#xD;
          -  Patient has an active autoimmune disease that has required systemic treatment in the&#xD;
             past 2 years.&#xD;
&#xD;
          -  Patient has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2,&#xD;
             anti-CTLA-4 including ipilimumab), or any other antibody or drug specifically&#xD;
             targeting T-cell co-stimulation or checkpoint pathways.&#xD;
&#xD;
          -  Patient has undergone prior treatment with a known PARP inhibitor.&#xD;
&#xD;
          -  Known history or current diagnosis of MDS or AML.&#xD;
&#xD;
          -  Patient has a known hypersensitivity to TSR-042 components or excipients.&#xD;
&#xD;
        For Parts B, D, E, F, G, H, and I, patients will not be eligible for study entry if any of&#xD;
        the following additional exclusion criterion are met:&#xD;
&#xD;
        • Patient has a known hypersensitivity to any of the following relevant study treatments:&#xD;
        carboplatin, paclitaxel, pemetrexed, nab-paclitaxel, or TSR-022 components or excipients.&#xD;
&#xD;
        For Parts C and D only, patients will not be eligible for study entry if the following&#xD;
        additional exclusion criterion is met:&#xD;
&#xD;
          -  Patient has clinically significant cardiovascular disease (e.g., significant cardiac&#xD;
             conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac&#xD;
             arrhythmia or unstable angina, New York Heart Association Grade 2 or greater&#xD;
             congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or&#xD;
             greater peripheral vascular disease, and history of cerebrovascular accident [CVA])&#xD;
             within 6 months of enrollment.&#xD;
&#xD;
          -  Patient has a history of bowel obstruction, including subocclusive disease, related to&#xD;
             the underlying disease and history of abdominal fistula, gastrointestinal perforation,&#xD;
             or intra abdominal abscesses. Evidence of recto-sigmoid involvement by pelvic&#xD;
             examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.&#xD;
&#xD;
          -  Patient has proteinuria as demonstrated by urine protein: creatinine ratio ≥1.0 at&#xD;
             screening or urine dipstick for proteinuria ≥2 (patients discovered to have ≥2&#xD;
             proteinuria on dipstick at baseline should undergo 24-hour urine collection and must&#xD;
             demonstrate &lt;2 g of protein in 24 hours to be eligible).&#xD;
&#xD;
          -  Patient is at increased bleeding risk due to concurrent conditions (e.g., major&#xD;
             injuries or surgery within the past 28 days prior to start of study treatment, history&#xD;
             of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or&#xD;
             clinically significant hemorrhage within the past 3 months).&#xD;
&#xD;
          -  Patient has a known hypersensitivity to bevacizumab components or excipients.&#xD;
&#xD;
        For Parts E and F only, patients will not be eligible for study entry if any of the&#xD;
        following additional exclusion criteria are met:&#xD;
&#xD;
          -  Patient is unable to interrupt aspirin or other nonsteroidal ant-inflammatory drugs,&#xD;
             other than an aspirin dose ≤ 1.3 g per day, for a 5-day period (8-day period for long&#xD;
             -acting agents, such as piroxicam.&#xD;
&#xD;
          -  Patient is unable or unwilling to take folic acid, vitamin B12 supplement.&#xD;
&#xD;
          -  Patient has symptomatic ascites or pleural effusion. A patient who is clinically&#xD;
             stable following treatment for these conditions (including therapeutic thoraco- or&#xD;
             paracentesis) is eligible.&#xD;
&#xD;
        For Parts G, H, and I only, patients will not be eligible for study entry if any of the&#xD;
        following additional exclusion criteria are met:&#xD;
&#xD;
        • Patient has pre-existing peripheral neuropathy that is Grade ≥ 2 by Common Terminology&#xD;
        Criteria for Adverse Events (CTCAE) version 4 criteria.&#xD;
&#xD;
        For Parts E, F, G, H and I only, patients will not be eligible for study entry if any of&#xD;
        the following additional exclusion criteria are met:&#xD;
&#xD;
        • Patient has interstitial lung disease or a history of pneumonitis that required oral or&#xD;
        intravenous glucocorticoids to assist with management.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Marcos</city>
        <state>California</state>
        <zip>92069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Yap TA, Bessudo A, Hamilton E, Sachdev J, Patel MR, Rodon J, Evilevitch L, Duncan M, Guo W, Kumar S, Lu S, Dezube BJ, Gabrail N. IOLite: phase 1b trial of doublet/triplet combinations of dostarlimab with niraparib, carboplatin-paclitaxel, with or without bevacizumab in patients with advanced cancer. J Immunother Cancer. 2022 Mar;10(3):e003924. doi: 10.1136/jitc-2021-003924.</citation>
    <PMID>35332062</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <results_first_submitted>February 24, 2021</results_first_submitted>
  <results_first_submitted_qc>April 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 10, 2021</results_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Niraparib</mesh_term>
    <mesh_term>Dostarlimab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03307785/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT03307785/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a multicenter, open-label study conducted in participants with advanced or metastatic cancer. The results presented are based on primary analysis up to maximum 28.5 months. Data collection is still on-going and additional results will be provided after study completion.</recruitment_details>
      <pre_assignment_details>A total of 58 participants were enrolled in the study. This was planned to be a nine part study with Parts A to I. However, Parts G, H and I were not initiated due to business strategic reason.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
          <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
        </group>
        <group group_id="P2">
          <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
        </group>
        <group group_id="P3">
          <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
        </group>
        <group group_id="P4">
          <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
        </group>
        <group group_id="P5">
          <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
        </group>
        <group group_id="P6">
          <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
        </group>
        <group group_id="P7">
          <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
        </group>
        <group group_id="P8">
          <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
        </group>
        <group group_id="P9">
          <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
          <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
        </group>
        <group group_id="P10">
          <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
          <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
        </group>
        <group group_id="P11">
          <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
          <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part A: Up to 28.5 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part B: Up to 28.5 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ongoing With Treatment in the Study</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part C: Up to 22.5 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ongoing With Treatment in the Study</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part D: Up to 9.5 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part E: Up to 4.4 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part F: Up to 3.5 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part G: Up to 24 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part H: Up to 24 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part I: Up to 24 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Parts G, H and I were not initiated due to business strategic reason. Hence, no participants were enrolled in Parts G, H and I.</population>
      <group_list>
        <group group_id="B1">
          <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
          <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
        </group>
        <group group_id="B2">
          <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
        </group>
        <group group_id="B3">
          <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
        </group>
        <group group_id="B4">
          <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
        </group>
        <group group_id="B5">
          <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
        </group>
        <group group_id="B6">
          <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
        </group>
        <group group_id="B7">
          <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
        </group>
        <group group_id="B8">
          <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
        </group>
        <group group_id="B9">
          <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
          <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
        </group>
        <group group_id="B10">
          <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
          <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
        </group>
        <group group_id="B11">
          <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
          <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
        </group>
        <group group_id="B12">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="14"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="7"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="2"/>
            <count group_id="B8" value="1"/>
            <count group_id="B9" value="0"/>
            <count group_id="B10" value="0"/>
            <count group_id="B11" value="0"/>
            <count group_id="B12" value="58"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>18-64 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>65-74 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="NA">Data is not reported due to participant confidentiality and privacy concerns.</measurement>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="NA">Data is not reported due to participant confidentiality and privacy concerns.</measurement>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="NA">Data is not reported due to participant confidentiality and privacy concerns.</measurement>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="NA">Data is not reported due to participant confidentiality and privacy concerns.</measurement>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Part A: Number of Participants With Dose-limiting Toxicity (DLT)</title>
        <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).</description>
        <time_frame>21 days</time_frame>
        <population>Safety Population consisted of all participants who received any amount of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Number of Participants With Dose-limiting Toxicity (DLT)</title>
          <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).</description>
          <population>Safety Population consisted of all participants who received any amount of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part B: Number of Participants With DLT</title>
        <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
        <time_frame>21 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Number of Participants With DLT</title>
          <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part C: Number of Participants With DLT</title>
        <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
        <time_frame>21 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Number of Participants With DLT</title>
          <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part D: Number of Participants With DLT</title>
        <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
        <time_frame>21 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Number of Participants With DLT</title>
          <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part E: Number of Participants With DLT</title>
        <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
        <time_frame>21 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Number of Participants With DLT</title>
          <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part F: Number of Participants With DLT</title>
        <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
        <time_frame>21 days</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Number of Participants With DLT</title>
          <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part G: Number of Participants With DLT</title>
        <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.</description>
        <time_frame>21 days</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Number of Participants With DLT</title>
          <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part H: Number of Participants With DLT</title>
        <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.</description>
        <time_frame>21 days</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Number of Participants With DLT</title>
          <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part I: Number of Participants With DLT</title>
        <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.</description>
        <time_frame>21 days</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Number of Participants With DLT</title>
          <description>An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for &gt;=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for &gt;=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for &gt;=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (&gt;2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
        <time_frame>Up to 28.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>STEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
        <time_frame>Up to 28.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>STEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
        <time_frame>Up to 22.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>STEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
        <time_frame>Up to 9.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>STEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
        <time_frame>Up to 4.4 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>STEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
        <time_frame>Up to 3.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.</description>
          <population>Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>STEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Objective Response Rate</title>
        <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
        <time_frame>Up to 28.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Objective Response Rate</title>
          <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Objective Response Rate</title>
        <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
        <time_frame>Up to 28.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Objective Response Rate</title>
          <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Objective Response Rate</title>
        <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
        <time_frame>Up to 22.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Objective Response Rate</title>
          <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Objective Response Rate</title>
        <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
        <time_frame>Up to 9.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Objective Response Rate</title>
          <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Objective Response Rate</title>
        <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
        <time_frame>Up to 4.4 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Objective Response Rate</title>
          <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Objective Response Rate</title>
        <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
        <time_frame>Up to 3.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Objective Response Rate</title>
          <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Objective Response Rate</title>
        <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Objective Response Rate</title>
          <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Objective Response Rate</title>
        <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Objective Response Rate</title>
          <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Objective Response Rate</title>
        <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Objective Response Rate</title>
          <description>Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be &lt;10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Duration of Response</title>
        <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
        <time_frame>Up to 28.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Duration of Response</title>
          <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
          <population>Safety Population.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.59" lower_limit="5.78" upper_limit="10.94"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Duration of response could not be calculated as no participants had a confirmed CR or PR in TSR-042 and niraparib 300 mg QD arm.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Duration of Response</title>
        <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause. Data is not reported as participants response is still ongoing at the time of primary analysis.</description>
        <time_frame>Up to 28.5 months</time_frame>
        <posting_date>04/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Duration of Response</title>
        <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause. Data is not reported as participants response is still ongoing at the time of primary analysis.</description>
        <time_frame>Up to 22.5 months</time_frame>
        <posting_date>04/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Duration of Response</title>
        <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause. Data is not reported as participants response is still ongoing at the time of primary analysis.</description>
        <time_frame>Up to 9.5 months</time_frame>
        <posting_date>04/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Duration of Response</title>
        <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
        <time_frame>Up to 4.4 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Duration of Response</title>
          <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
          <population>Safety Population.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Duration of response could not be calculated as no participants had a confirmed CR or PR.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Duration of Response</title>
        <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
        <time_frame>Up to 3.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Duration of Response</title>
          <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
          <population>Safety Population.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and full range could not be calculated as there were no confirmed CR or PR.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Duration of Response</title>
        <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Duration of Response</title>
          <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Duration of Response</title>
        <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Duration of Response</title>
          <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Duration of Response</title>
        <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Duration of Response</title>
          <description>Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Disease Control Rate</title>
        <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.</description>
        <time_frame>Up to 28.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Disease Control Rate</title>
          <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.8"/>
                    <measurement group_id="O2" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Disease Control Rate</title>
        <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
        <time_frame>Up to 28.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Disease Control Rate</title>
          <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Disease Control Rate</title>
        <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
        <time_frame>Up to 22.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Disease Control Rate</title>
          <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3"/>
                    <measurement group_id="O2" value="85.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Disease Control Rate</title>
        <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
        <time_frame>Up to 9.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Disease Control Rate</title>
          <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Disease Control Rate</title>
        <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
        <time_frame>Up to 4.4 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Disease Control Rate</title>
          <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Disease Control Rate</title>
        <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
        <time_frame>Up to 3.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Disease Control Rate</title>
          <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
          <population>Safety Population.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Disease Control Rate</title>
        <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Disease Control Rate</title>
          <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Disease Control Rate</title>
        <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Disease Control Rate</title>
          <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Disease Control Rate</title>
        <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Disease Control Rate</title>
          <description>Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Progression-free Survival</title>
        <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
        <time_frame>Up to 28.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Progression-free Survival</title>
          <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
          <population>Safety Population.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" lower_limit="2.2" upper_limit="9.9"/>
                    <measurement group_id="O2" value="2.8" lower_limit="2.3" upper_limit="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Progression-free Survival</title>
        <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
        <time_frame>Up to 28.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Progression-free Survival</title>
          <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
          <population>Safety Population.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6" lower_limit="3.9" upper_limit="NA">&lt;75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Progression-free Survival</title>
        <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
        <time_frame>Up to 22.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Progression-free Survival</title>
          <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
          <population>Safety Population.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="8.5" upper_limit="NA">&lt;50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.</measurement>
                    <measurement group_id="O2" value="9.1" lower_limit="8.0" upper_limit="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Progression-free Survival</title>
        <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
        <time_frame>Up to 9.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Progression-free Survival</title>
          <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
          <population>Safety Population.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" lower_limit="7.4" upper_limit="NA">&lt;75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Progression-free Survival</title>
        <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
        <time_frame>Up to 4.4 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Progression-free Survival</title>
          <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
          <population>Safety Population.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and Inter Quartile range could not be estimated due to the low number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Progression-free Survival</title>
        <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
        <time_frame>Up to 3.5 months</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Progression-free Survival</title>
          <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.</description>
          <population>Safety Population.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Median and Inter Quartile range could not be estimated due to the low number of participant with event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Progression-free Survival</title>
        <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Progression-free Survival</title>
          <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Progression-free Survival</title>
        <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Progression-free Survival</title>
          <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Progression-free Survival</title>
        <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Progression-free Survival</title>
          <description>Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.</description>
          <population>Safety Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
        <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.</description>
        <time_frame>Up to 28.5 months</time_frame>
        <population>Anti-drug Antibody Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
          <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.</description>
          <population>Anti-drug Antibody Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
        <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
        <time_frame>Up to 28.5 months</time_frame>
        <population>Anti-drug Antibody Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
          <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
          <population>Anti-drug Antibody Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
        <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
        <time_frame>Up to 22.5 months</time_frame>
        <population>Anti-drug Antibody Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
          <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
          <population>Anti-drug Antibody Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
        <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
        <time_frame>Up to 9.5 months</time_frame>
        <population>Anti-drug Antibody Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
          <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
          <population>Anti-drug Antibody Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
        <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
        <time_frame>Up to 4.4 months</time_frame>
        <population>Anti-drug Antibody Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
          <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
          <population>Anti-drug Antibody Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
        <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
        <time_frame>Up to 3.5 months</time_frame>
        <population>Anti-drug Antibody Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
          <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
          <population>Anti-drug Antibody Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Data could not be calculated due to insufficient participant with data.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Number of Participants With Positive Anti-TSR-022 Antibodies</title>
        <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
        <time_frame>Up to 3.5 months</time_frame>
        <population>Anti-drug Antibody Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Number of Participants With Positive Anti-TSR-022 Antibodies</title>
          <description>Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
          <population>Anti-drug Antibody Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Data could not be calculated due to insufficient participant with data.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
        <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
          <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
          <population>Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
        <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
          <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
          <population>Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Number of Participants With Positive Anti-TSR-022 Antibodies</title>
        <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Number of Participants With Positive Anti-TSR-022 Antibodies</title>
          <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
          <population>Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
        <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Number of Participants With Positive Anti-TSR-042 Antibodies</title>
          <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
          <population>Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Number of Participants With Positive Anti-TSR-022 Antibodies</title>
        <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Number of Participants With Positive Anti-TSR-022 Antibodies</title>
          <description>Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).</description>
          <population>Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.</description>
        <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=15,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0430" spread="3.43261"/>
                    <measurement group_id="O2" value="7.8341" spread="4.76380"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2, n=10,3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9172" spread="9.82689"/>
                    <measurement group_id="O2" value="29.3024" spread="2.15129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: AUC(0-t) of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: AUC(0-t) of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=16,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26827.7703" spread="9811.74994"/>
                    <measurement group_id="O2" value="29420.8347" spread="9262.18751"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4, n=9,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55408.3992" spread="21631.17124"/>
                    <measurement group_id="O2" value="29311.8182" spread="16546.73177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137108.2574" spread="41494.15474"/>
                    <measurement group_id="O2" value="141328.9288" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=5,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139591.8834" spread="53844.12650"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: AUC0-t of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: AUC0-t of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28097.9846" spread="8440.50578"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54730.0053" spread="15857.69305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124309.5455" spread="56505.10671"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117030.4081" spread="33852.45635"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: AUC0-t of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: AUC0-t of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=6,7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4513" spread="1.23048"/>
                    <measurement group_id="O2" value="11.3601" spread="5.53524"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2, n=4,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7473" spread="8.11715"/>
                    <measurement group_id="O2" value="24.9691" spread="17.50367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: AUC0-t of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: AUC0-t of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=6,7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29830.6542" spread="8143.36941"/>
                    <measurement group_id="O2" value="26311.1789" spread="4416.61957"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4, n=5,7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54268.1379" spread="14777.09545"/>
                    <measurement group_id="O2" value="49198.8237" spread="12507.66126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137777.3188" spread="45794.21973"/>
                    <measurement group_id="O2" value="131281.9046" spread="36835.39730"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143070.3093" spread="74219.00272"/>
                    <measurement group_id="O2" value="119161.8795" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: AUC0-t of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: AUC0-t of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32819.5401" spread="9182.44511"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52409.0255" spread="11814.13244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119847.0999" spread="27279.85524"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77794.6422" spread="38680.64753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: AUC0-t of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: AUC0-t of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate AUC0-t.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: AUC0-t of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: AUC0-t of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate AUC0-t.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: AUC0-t of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: AUC0-t of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate AUC0-t.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: AUC0-t of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: AUC0-t of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: AUC0-t of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: AUC0-t of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: AUC0-t of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: AUC0-t of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: AUC0-t of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: AUC0-t of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: AUC0-t of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: AUC0-t of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: AUC(0-infinity) of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: AUC(0-infinity) of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: AUC(0-infinity) of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: AUC(0-infinity) of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: AUC(0-infinity) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: AUC(0-infinity) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: AUC(0-infinity) of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: AUC(0-infinity) of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: AUC(0-infinity) of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: AUC(0-infinity) of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: AUC(0-infinity) of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: AUC(0-infinity) of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: AUC(0-infinity) of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: AUC(0-infinity) of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: AUC(0-infinity) of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: AUC(0-infinity) of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: AUC(0-infinity) of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: AUC(0-infinity) of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: AUC(0-infinity) of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: AUC(0-infinity) of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: AUC(0-infinity) of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: AUC(0-infinity) of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: AUC(0-infinity) of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: AUC(0-infinity) of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: AUC(0-infinity) of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: AUC(0-infinity) of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.191953" spread="0.1309536"/>
                    <measurement group_id="O2" value="0.342333" spread="0.3301392"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Ctau of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Ctau of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.6000" spread="12.25194"/>
                    <measurement group_id="O2" value="29.8000" spread="10.32570"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Ctau of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Ctau of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.9778" spread="9.89846"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Ctau of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Ctau of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.161233" spread="0.1072328"/>
                    <measurement group_id="O2" value="0.478714" spread="0.4197538"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Ctau of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Ctau of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.2750" spread="16.78102"/>
                    <measurement group_id="O2" value="28.7500" spread="9.47505"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Ctau of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Ctau of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.5250" spread="12.29834"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Ctau of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Ctau of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Ctau.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Ctau of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Ctau of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Ctau.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Ctau of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Ctau of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Ctau.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Ctau of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Ctau of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Ctau of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Ctau of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Ctau of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Ctau of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Ctau of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Ctau of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Ctau of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Ctau of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Maximum Observed Plasma (Cmax) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Maximum Observed Plasma (Cmax) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.460600" spread="0.2401100"/>
                    <measurement group_id="O2" value="0.625667" spread="0.4547692"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Cmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Cmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158.6875" spread="27.70251"/>
                    <measurement group_id="O2" value="138.9167" spread="37.87930"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Cmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Cmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148.2000" spread="31.27948"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Cmax of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Cmax of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.243667" spread="0.0889936"/>
                    <measurement group_id="O2" value="0.891571" spread="0.4638897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Cmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Cmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138.6667" spread="24.14677"/>
                    <measurement group_id="O2" value="158.4857" spread="48.36788"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Cmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Cmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="188.5000" spread="36.04858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Cmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Cmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Cmax.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Cmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Cmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Cmax.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Cmax of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Cmax of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Cmax.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Cmax of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Cmax of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Cmax of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Cmax of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Cmax of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Cmax of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Cmax of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Cmax of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Cmax of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Cmax of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Clearance After Oral Administration (CL/F) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Clearance After Oral Administration (CL/F) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=1,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5638" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2, n=8,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.6295" spread="8.70836"/>
                    <measurement group_id="O2" value="10.2833" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Clearance After Intravenous Administration (CL) of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Clearance After Intravenous Administration (CL) of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 4, n=7,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0090" spread="0.00220"/>
                    <measurement group_id="O2" value="0.0110" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0081" spread="0.00238"/>
                    <measurement group_id="O2" value="0.0071" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0072" spread="0.00217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: CL of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: CL of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 4, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0098" spread="0.00292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0082" spread="0.00242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0092" spread="0.00296"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: CL/F of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: CL/F of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 2, n=2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3777" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                    <measurement group_id="O2" value="14.4947" spread="8.40967"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: CL of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: CL of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 4, n=5,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0100" spread="0.00441"/>
                    <measurement group_id="O2" value="0.0104" spread="0.00268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0082" spread="0.00370"/>
                    <measurement group_id="O2" value="0.0082" spread="0.00273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0079" spread="0.00391"/>
                    <measurement group_id="O2" value="0.0086" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: CL of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: CL of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 4, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0102" spread="0.00210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0087" spread="0.00169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0104" spread="0.00100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: CL of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: CL of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate CL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: CL of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: CL of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate CL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: CL of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: CL of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate CL.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: CL of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: CL of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: CL of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: CL of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: CL of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: CL of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: CL of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: CL of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: CL of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: CL of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=1,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="380.1478" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2, n=8,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="716.1418" spread="554.80278"/>
                    <measurement group_id="O2" value="487.8826" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 4, n=5,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6925" spread="1.46062"/>
                    <measurement group_id="O2" value="10.3984" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8811" spread="1.70545"/>
                    <measurement group_id="O2" value="6.3070" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4795" spread="0.90952"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Vz of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Vz of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 4, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3661" spread="2.01321"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2627" spread="2.43311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0529" spread="3.64454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Vz/F of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Vz/F of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 2, n=2,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="551.4003" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                    <measurement group_id="O2" value="559.3634" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Vz of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Vz of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 4, n=5,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6462" spread="2.66825"/>
                    <measurement group_id="O2" value="5.8922" spread="2.93257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=4,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1698" spread="1.73272"/>
                    <measurement group_id="O2" value="5.2066" spread="1.07206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6347" spread="4.05466"/>
                    <measurement group_id="O2" value="8.5098" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Vz of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Vz of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1, n=0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 4, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4955" spread="1.89543"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1542" spread="1.57345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8356" spread="0.99107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Vz of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Vz of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Vz.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Vz of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Vz of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Vz.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Vz of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Vz of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Vz.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Vz of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Vz of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Vz of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Vz of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Vz of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Vz of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Vz of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Vz of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Vz of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Vz of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: AUC at Steady State (AUCss) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: AUC at Steady State (AUCss) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3481" spread="10.63803"/>
                    <measurement group_id="O2" value="29.4312" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: AUCss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: AUCss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=7,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58598.5076" spread="15328.61731"/>
                    <measurement group_id="O2" value="46122.3924" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135171.2753" spread="43806.32512"/>
                    <measurement group_id="O2" value="141306.3782" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151575.3645" spread="55194.65972"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: AUCss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: AUCss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55073.0926" spread="15304.21896"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130694.9752" spread="33923.75772"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117033.3612" spread="33727.51653"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: AUCss of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: AUCss of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4926" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                    <measurement group_id="O2" value="26.5006" spread="14.61077"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: AUCss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: AUCss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=5,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55974.4268" spread="16738.05254"/>
                    <measurement group_id="O2" value="50924.1510" spread="13339.28085"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137399.5881" spread="45511.62023"/>
                    <measurement group_id="O2" value="131288.0291" spread="36816.18787"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147907.5379" spread="60795.87607"/>
                    <measurement group_id="O2" value="119189.5905" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: AUCss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: AUCss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51140.4410" spread="12597.07380"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118845.3928" spread="27874.98871"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96800.1534" spread="8871.32089"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: AUCss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: AUCss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate AUCss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: AUCss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: AUCss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate AUCss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: AUCss of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: AUCss of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate AUCss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: AUCss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: AUCss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: AUCss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: AUCss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: AUCss of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: AUCss of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: AUCss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: AUCss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: AUCss of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: AUCss of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Ctau at Steady State (Ctau,ss) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Ctau at Steady State (Ctau,ss) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 2, n=11,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.507900" spread="0.3937657"/>
                    <measurement group_id="O2" value="0.622000" spread="0.4523848"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 11, n=0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Ctau,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Ctau,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=8,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.3625" spread="28.55145"/>
                    <measurement group_id="O2" value="63.3000" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.5500" spread="34.63879"/>
                    <measurement group_id="O2" value="71.2000" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.8000" spread="47.28939"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Ctau,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Ctau,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.2444" spread="24.15130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.3000" spread="16.75913"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.4833" spread="20.98136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Ctau,ss of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Ctau,ss of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 2, n=5,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.484000" spread="0.3511339"/>
                    <measurement group_id="O2" value="1.094250" spread="0.7660576"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 11, n=0,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Ctau,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Ctau,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=4,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.4250" spread="34.00896"/>
                    <measurement group_id="O2" value="64.2667" spread="23.55315"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.9800" spread="43.98252"/>
                    <measurement group_id="O2" value="53.1500" spread="24.80538"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=3,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.4667" spread="22.28909"/>
                    <measurement group_id="O2" value="60.9500" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Ctau,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Ctau,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.5200" spread="13.87271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.0800" spread="23.95343"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3000" spread="4.80729"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Ctau,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Ctau,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Ctau,ss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Ctau,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Ctau,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Ctau,ss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Ctau,ss of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Ctau,ss of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Ctau,ss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Ctau,ss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Ctau,ss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Ctau,ss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Ctau,ss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Ctau,ss of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Ctau,ss of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Ctau,ss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Ctau,ss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Ctau,ss of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Ctau,ss of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Cmax at Steady State (Cmax,ss) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Cmax at Steady State (Cmax,ss) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 2, n=10,3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.925900" spread="0.6661597"/>
                    <measurement group_id="O2" value="1.706667" spread="0.0838650"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=7,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.839071" spread="0.6183628"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=2,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.768000" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Cmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Cmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=9,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222.5556" spread="51.37633"/>
                    <measurement group_id="O2" value="178.5000" spread="26.18524"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="393.8750" spread="100.81729"/>
                    <measurement group_id="O2" value="319.0000" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=5,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="405.4000" spread="103.69812"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Cmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Cmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="225.8000" spread="51.71460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="421.1111" spread="114.84603"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="446.6667" spread="160.53868"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Cmax,ss of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Cmax,ss of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 2, n=4,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.854500" spread="0.3934637"/>
                    <measurement group_id="O2" value="1.404750" spread="0.6642366"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=4,3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.709750" spread="0.2693788"/>
                    <measurement group_id="O2" value="1.073667" spread="0.5474124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=3,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.468333" spread="0.1418955"/>
                    <measurement group_id="O2" value="0.638000" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Cmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Cmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=5,7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="234.4000" spread="31.76948"/>
                    <measurement group_id="O2" value="227.1429" spread="42.65923"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="325.2000" spread="73.90332"/>
                    <measurement group_id="O2" value="417.3333" spread="139.40397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="349.7500" spread="111.53886"/>
                    <measurement group_id="O2" value="321.0000" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Cmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Cmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="256.8000" spread="76.90709"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="416.0000" spread="89.43433"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="429.7500" spread="72.86231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Cmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Cmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Cmax,ss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Cmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Cmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Cmax,ss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Cmax,ss of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Cmax,ss of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Cmax,ss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Cmax,ss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Cmax,ss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Cmax,ss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Cmax,ss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Cmax,ss of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Cmax,ss of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Cmax,ss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Cmax,ss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Cmax,ss of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Cmax,ss of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.250" lower_limit="1.75" upper_limit="7.02"/>
                    <measurement group_id="O2" value="4.083" lower_limit="2.02" upper_limit="25.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Tmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Tmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.817" lower_limit="0.50" upper_limit="2.58"/>
                    <measurement group_id="O2" value="1.750" lower_limit="0.50" upper_limit="23.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Tmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Tmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="0.55" upper_limit="27.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Tmax of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Tmax of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.975" lower_limit="2.00" upper_limit="23.33"/>
                    <measurement group_id="O2" value="4.050" lower_limit="2.05" upper_limit="22.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Tmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Tmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.200" lower_limit="0.50" upper_limit="4.48"/>
                    <measurement group_id="O2" value="0.583" lower_limit="0.50" upper_limit="2.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Tmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Tmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.250" lower_limit="0.50" upper_limit="25.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Tmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Tmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Data was not collected due to insufficient number of participants with data to calculate Tmax.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Tmax of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Tmax of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Data was not collected due to insufficient number of participants with data to calculate Tmax.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Tmax of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Tmax of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Data was not collected due to insufficient number of participants with data to calculate Tmax.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Tmax of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Tmax of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Tmax of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Tmax of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Tmax of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Tmax of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Tmax of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Tmax of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Tmax of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Tmax of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Tmax at Steady State (Tmax,ss) of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Tmax at Steady State (Tmax,ss) of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 2, n=10,3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.008" lower_limit="1.00" upper_limit="22.68"/>
                    <measurement group_id="O2" value="2.250" lower_limit="2.08" upper_limit="7.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=7,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.000" lower_limit="0.00" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=2,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.817" lower_limit="1.75" upper_limit="1.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Tmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Tmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=9,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.500" lower_limit="0.50" upper_limit="2.07"/>
                    <measurement group_id="O2" value="1.300" lower_limit="0.50" upper_limit="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.625" lower_limit="0.50" upper_limit="1.73"/>
                    <measurement group_id="O2" value="2.783" lower_limit="NA" upper_limit="NA">Full range is not applicable due to single participant, and the median value presented here is the actual tmax,ss for this single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=5,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.567" lower_limit="0.50" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Tmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Tmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.575" lower_limit="0.50" upper_limit="2.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.500" lower_limit="0.50" upper_limit="2.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.542" lower_limit="0.42" upper_limit="2.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Tmax,ss of Niraparib</title>
        <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Tmax,ss of Niraparib</title>
          <description>Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 2, n=4,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.950" lower_limit="2.03" upper_limit="22.30"/>
                    <measurement group_id="O2" value="3.958" lower_limit="2.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=4,3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.158" lower_limit="1.82" upper_limit="2.68"/>
                    <measurement group_id="O2" value="1.967" lower_limit="1.17" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=3,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.000" lower_limit="0.00" upper_limit="2.00"/>
                    <measurement group_id="O2" value="2.083" lower_limit="NA" upper_limit="NA">Full range is not applicable due to single participant, and the median value presented here is the actual tmax,ss for this single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Tmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Tmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=5,7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.517" lower_limit="0.50" upper_limit="20.67"/>
                    <measurement group_id="O2" value="0.617" lower_limit="0.50" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.083" lower_limit="0.50" upper_limit="2.58"/>
                    <measurement group_id="O2" value="0.825" lower_limit="0.50" upper_limit="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.000" lower_limit="1.98" upper_limit="2.00"/>
                    <measurement group_id="O2" value="2.417" lower_limit="2.17" upper_limit="2.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Tmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Tmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.50" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.550" lower_limit="0.50" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.50" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Tmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Tmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Tmax,ss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Tmax,ss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Tmax,ss of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Tmax,ss of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Tmax,ss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Tmax,ss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Tmax,ss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Tmax,ss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Tmax,ss of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Tmax,ss of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Tmax,ss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Tmax,ss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Tmax,ss of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Tmax,ss of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
            <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
          </group>
          <group group_id="O2">
            <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
          </group>
        </group_list>
        <measure>
          <title>Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=5,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5647" spread="1.36694"/>
                    <measurement group_id="O2" value="9.8680" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6580" spread="1.53521"/>
                    <measurement group_id="O2" value="5.9659" spread="NA">Standard deviation could not be calculated for single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3107" spread="0.96007"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Vss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Vss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1893" spread="1.80311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7701" spread="2.31992"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4351" spread="2.78481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part C: Vss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
          <group group_id="O2">
            <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part C: Vss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=5,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4567" spread="2.68944"/>
                    <measurement group_id="O2" value="5.5177" spread="2.39652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=4,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2405" spread="1.79539"/>
                    <measurement group_id="O2" value="4.8035" spread="0.72905"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9478" spread="3.05769"/>
                    <measurement group_id="O2" value="7.7750" spread="NA">Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part D: Vss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Part D: Vss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1493" spread="1.58340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5, n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6399" spread="1.41478"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11, n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0614" spread="0.48037"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part E: Vss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part E: Vss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Vss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Vss of TSR-042</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Vss of TSR-042</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Vss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part F: Vss of TSR-022</title>
        <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
            <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
          </group>
        </group_list>
        <measure>
          <title>Part F: Vss of TSR-022</title>
          <description>Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.</description>
          <population>PK Population.</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected due to insufficient number of participants with data to calculate Vss.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part G: Vss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
        <group_list>
          <group group_id="O1">
            <title>Part G: TSR-042 and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part G: Vss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part G.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Vss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Vss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part H: Vss of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
        <group_list>
          <group group_id="O1">
            <title>Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Part H: Vss of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part H.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Vss of TSR-042</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Vss of TSR-042</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part I: Vss of TSR-022</title>
        <description>Blood samples were planned to be collected at indicated time points.</description>
        <time_frame>Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)</time_frame>
        <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel</title>
            <description>Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Part I: Vss of TSR-022</title>
          <description>Blood samples were planned to be collected at indicated time points.</description>
          <population>PK Population. Data was not collected as no participants were enrolled in Part I.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A and B; up to 22.5 months in Part C; up to 9.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F</time_frame>
      <desc>Safety Population. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. The results presented are based on primary analysis up to maximum 28.5 months. Data collection is still on-going and additional results will be provided after study completion.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part A: TSR-042 and Niraparib 200 mg QD</title>
          <description>Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.</description>
        </group>
        <group group_id="E2">
          <title>Part A: TSR-042 and Niraparib 300 mg QD</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.</description>
        </group>
        <group group_id="E3">
          <title>Part B: TSR-042 and Carboplatin-paclitaxel</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.</description>
        </group>
        <group group_id="E4">
          <title>Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
        </group>
        <group group_id="E5">
          <title>Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
        </group>
        <group group_id="E6">
          <title>Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.</description>
        </group>
        <group group_id="E7">
          <title>Part E: TSR-042 and Carboplatin-pemetrexed</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).</description>
        </group>
        <group group_id="E8">
          <title>Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed</title>
          <description>Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Staphylococcal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Posterior reversible encephalopathy syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vertebral artery dissection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E2" events="9" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" events="27" subjects_affected="10" subjects_at_risk="14"/>
                <counts group_id="E4" events="9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="10" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E6" events="10" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E7" events="6" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E8" events="12" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haemolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="9" subjects_affected="6" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="15" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="5" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="19" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Left ventricular hypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dacryostenosis acquired</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Eye haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ophthalmoplegia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E6" events="6" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E6" events="21" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhoea haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Faeces hard</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastric disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypertrophy of tongue papillae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mouth haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="16"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" events="6" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E6" events="9" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" events="4" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oral discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tooth loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="11" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E6" events="4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cyst rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E6" events="7" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="5" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Temperature intolerance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bacterial vaginosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bacterial vulvovaginitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dacryocystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Stoma site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Radiation injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Recall phenomenon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="6" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood folate decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood testosterone decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Breath sounds abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="6" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="3" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="6" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tri-iodothyronine decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vitamin B12 decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="6" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="5" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="8" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" events="4" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="5" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="9" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="11" subjects_affected="6" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Soft tissue mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Autonomic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperreflexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Post herpetic neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hallucination, visual</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Leukocyturia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="9" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E6" events="7" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Postmenopausal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pruritus genital</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vulvovaginal dryness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchial secretion retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="7" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Immune-mediated pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sputum discoloured</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper airway obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="6" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nail discolouration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nail ridging</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pigmentation disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="8" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" events="5" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pallor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03307785
org study id: 213351
secondary id: 3000-01-002
nct id: NCT03307785
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Part A: To test the safety and tolerability of combination therapy with Niraparib and TSR-042
      and to establish a safe dose that will be used in a Phase 2 study.

      Part B: To test the safety and tolerability of combination therapy with
      Carboplatin-Paclitaxel and TSR-042 and to establish a safe dose that will be used in a Phase
      2 study.

      Part C: To test the safety and tolerability of combination therapy with Niraparib, TSR-042
      and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study.

      Part D: To test the safety and tolerability of combination therapy with
      Carboplatin-Paclitaxel, TSR-042 and Bevacizumab and to establish a safe dose that will be
      used in a Phase 2 study.

      Part E: To test the safety and tolerability of combination therapy with
      Carboplatin-Pemetrexed and TSR-042 and to establish a safe dose that will be used in a Phase
      2 study.

      Part F: To test the safety and tolerability of combination therapy with
      Carboplatin-Pemetrexed, TSR-022 and TSR-042 and to establish a safe dose that will be used in
      a Phase 2 study.

      Part G: To test the safety and tolerability of combination therapy with
      Carboplatin-nab-Paclitaxel, TSR-042 and to establish a safe dose that will be used in a Phase
      2 study.

      Part H: To test the safety and tolerability of combination therapy with
      Carboplatin-nab-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be
      used in a Phase 2 study.

      Part I: To test the safety and tolerability of combination therapy with
      Carboplatin-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in
      a Phase 2 study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Part A: Number of Participants With Dose-limiting Toxicity (DLT)
time frame: 21 days
description: An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).
measure: Part B: Number of Participants With DLT
time frame: 21 days
description: An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
measure: Part C: Number of Participants With DLT
time frame: 21 days
description: An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
measure: Part D: Number of Participants With DLT
time frame: 21 days
description: An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
measure: Part E: Number of Participants With DLT
time frame: 21 days
description: An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
measure: Part F: Number of Participants With DLT
time frame: 21 days
description: An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
measure: Part G: Number of Participants With DLT
time frame: 21 days
description: An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
measure: Part H: Number of Participants With DLT
time frame: 21 days
description: An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
measure: Part I: Number of Participants With DLT
time frame: 21 days
description: An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for >=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for >=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for >=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
measure: Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)
time frame: Up to 28.5 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
measure: Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
time frame: Up to 28.5 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
measure: Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
time frame: Up to 22.5 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
measure: Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
time frame: Up to 9.5 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
measure: Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
time frame: Up to 4.4 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
measure: Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
time frame: Up to 3.5 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
measure: Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
time frame: Up to 24 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
measure: Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
time frame: Up to 24 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
measure: Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
time frame: Up to 24 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
measure: Part A: Objective Response Rate
time frame: Up to 28.5 months
description: Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
measure: Part B: Objective Response Rate
time frame: Up to 28.5 months
description: Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
measure: Part C: Objective Response Rate
time frame: Up to 22.5 months
description: Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
measure: Part D: Objective Response Rate
time frame: Up to 9.5 months
description: Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
measure: Part E: Objective Response Rate
time frame: Up to 4.4 months
description: Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
measure: Part F: Objective Response Rate
time frame: Up to 3.5 months
description: Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
measure: Part G: Objective Response Rate
time frame: Up to 24 months
description: Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
measure: Part H: Objective Response Rate
time frame: Up to 24 months
description: Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
measure: Part I: Objective Response Rate
time frame: Up to 24 months
description: Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
measure: Part A: Duration of Response
time frame: Up to 28.5 months
description: Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
measure: Part B: Duration of Response
time frame: Up to 28.5 months
description: Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause. Data is not reported as participants response is still ongoing at the time of primary analysis.
measure: Part C: Duration of Response
time frame: Up to 22.5 months
description: Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause. Data is not reported as participants response is still ongoing at the time of primary analysis.
measure: Part D: Duration of Response
time frame: Up to 9.5 months
description: Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause. Data is not reported as participants response is still ongoing at the time of primary analysis.
measure: Part E: Duration of Response
time frame: Up to 4.4 months
description: Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
measure: Part F: Duration of Response
time frame: Up to 3.5 months
description: Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
measure: Part G: Duration of Response
time frame: Up to 24 months
description: Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
measure: Part H: Duration of Response
time frame: Up to 24 months
description: Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
measure: Part I: Duration of Response
time frame: Up to 24 months
description: Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
measure: Part A: Disease Control Rate
time frame: Up to 28.5 months
description: Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.
measure: Part B: Disease Control Rate
time frame: Up to 28.5 months
description: Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
measure: Part C: Disease Control Rate
time frame: Up to 22.5 months
description: Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
measure: Part D: Disease Control Rate
time frame: Up to 9.5 months
description: Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
measure: Part E: Disease Control Rate
time frame: Up to 4.4 months
description: Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
measure: Part F: Disease Control Rate
time frame: Up to 3.5 months
description: Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
measure: Part G: Disease Control Rate
time frame: Up to 24 months
description: Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
measure: Part H: Disease Control Rate
time frame: Up to 24 months
description: Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
measure: Part I: Disease Control Rate
time frame: Up to 24 months
description: Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
measure: Part A: Progression-free Survival
time frame: Up to 28.5 months
description: Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
measure: Part B: Progression-free Survival
time frame: Up to 28.5 months
description: Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
measure: Part C: Progression-free Survival
time frame: Up to 22.5 months
description: Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
measure: Part D: Progression-free Survival
time frame: Up to 9.5 months
description: Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
measure: Part E: Progression-free Survival
time frame: Up to 4.4 months
description: Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
measure: Part F: Progression-free Survival
time frame: Up to 3.5 months
description: Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
measure: Part G: Progression-free Survival
time frame: Up to 24 months
description: Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
measure: Part H: Progression-free Survival
time frame: Up to 24 months
description: Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
measure: Part I: Progression-free Survival
time frame: Up to 24 months
description: Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
measure: Part A: Number of Participants With Positive Anti-TSR-042 Antibodies
time frame: Up to 28.5 months
description: Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.
measure: Part B: Number of Participants With Positive Anti-TSR-042 Antibodies
time frame: Up to 28.5 months
description: Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
measure: Part C: Number of Participants With Positive Anti-TSR-042 Antibodies
time frame: Up to 22.5 months
description: Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
measure: Part D: Number of Participants With Positive Anti-TSR-042 Antibodies
time frame: Up to 9.5 months
description: Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
measure: Part E: Number of Participants With Positive Anti-TSR-042 Antibodies
time frame: Up to 4.4 months
description: Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
measure: Part F: Number of Participants With Positive Anti-TSR-042 Antibodies
time frame: Up to 3.5 months
description: Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
measure: Part F: Number of Participants With Positive Anti-TSR-022 Antibodies
time frame: Up to 3.5 months
description: Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
measure: Part G: Number of Participants With Positive Anti-TSR-042 Antibodies
time frame: Up to 24 months
description: Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
measure: Part H: Number of Participants With Positive Anti-TSR-042 Antibodies
time frame: Up to 24 months
description: Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
measure: Part H: Number of Participants With Positive Anti-TSR-022 Antibodies
time frame: Up to 24 months
description: Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
measure: Part I: Number of Participants With Positive Anti-TSR-042 Antibodies
time frame: Up to 24 months
description: Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
measure: Part I: Number of Participants With Positive Anti-TSR-022 Antibodies
time frame: Up to 24 months
description: Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
measure: Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib
time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.
measure: Part A: AUC(0-t) of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: AUC0-t of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: AUC0-t of Niraparib
time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part C: AUC0-t of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: AUC0-t of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: AUC0-t of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: AUC0-t of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: AUC0-t of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: AUC0-t of TSR-042
time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: AUC0-t of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: AUC0-t of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: AUC0-t of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: AUC0-t of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib
time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part A: AUC(0-infinity) of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: AUC(0-infinity) of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: AUC(0-infinity) of Niraparib
time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part C: AUC(0-infinity) of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: AUC(0-infinity) of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: AUC(0-infinity) of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: AUC(0-infinity) of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: AUC(0-infinity) of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: AUC(0-infinity) of TSR-042
time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: AUC(0-infinity) of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: AUC(0-infinity) of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: AUC(0-infinity) of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: AUC(0-infinity) of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib
time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part A: Ctau of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: Ctau of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: Ctau of Niraparib
time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part C: Ctau of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: Ctau of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: Ctau of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Ctau of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Ctau of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: Ctau of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Ctau of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Ctau of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Ctau of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Ctau of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part A: Maximum Observed Plasma (Cmax) of Niraparib
time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part A: Cmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: Cmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: Cmax of Niraparib
time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part C: Cmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: Cmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: Cmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Cmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Cmax of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: Cmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Cmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Cmax of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Cmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Cmax of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part A: Clearance After Oral Administration (CL/F) of Niraparib
time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part A: Clearance After Intravenous Administration (CL) of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: CL of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: CL/F of Niraparib
time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part C: CL of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: CL of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: CL of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: CL of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: CL of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: CL of TSR-042
time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: CL of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: CL of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: CL of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: CL of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib
time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: Vz of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: Vz/F of Niraparib
time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part C: Vz of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: Vz of TSR-042
time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: Vz of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Vz of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Vz of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: Vz of TSR-042
time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Vz of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Vz of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Vz of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Vz of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part A: AUC at Steady State (AUCss) of Niraparib
time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part A: AUCss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: AUCss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: AUCss of Niraparib
time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part C: AUCss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: AUCss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: AUCss of TSR-042
time frame: Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: AUCss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: AUCss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: AUCss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: AUCss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: AUCss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: AUCss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: AUCss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part A: Ctau at Steady State (Ctau,ss) of Niraparib
time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part A: Ctau,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: Ctau,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: Ctau,ss of Niraparib
time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part C: Ctau,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: Ctau,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: Ctau,ss of TSR-042
time frame: Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Ctau,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Ctau,ss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: Ctau,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Ctau,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Ctau,ss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Ctau,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Ctau,ss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part A: Cmax at Steady State (Cmax,ss) of Niraparib
time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part A: Cmax,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: Cmax,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: Cmax,ss of Niraparib
time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part C: Cmax,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: Cmax,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: Cmax,ss of TSR-042
time frame: Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Cmax,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Cmax,ss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: Cmax,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Cmax,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Cmax,ss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Cmax,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Cmax,ss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib
time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part A: Tmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: Tmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: Tmax of Niraparib
time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part C: Tmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: Tmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: Tmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Tmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Tmax of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: Tmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Tmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Tmax of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Tmax of TSR-042
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Tmax of TSR-022
time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part A: Tmax at Steady State (Tmax,ss) of Niraparib
time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part A: Tmax,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: Tmax,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: Tmax,ss of Niraparib
time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
measure: Part C: Tmax,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: Tmax,ss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: Tmax,ss of TSR-042
time frame: Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Tmax,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Tmax,ss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: Tmax,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Tmax,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Tmax,ss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Tmax,ss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Tmax,ss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part B: Vss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part C: Vss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part D: Vss of TSR-042
time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part E: Vss of TSR-042
time frame: Cycle 2: Pre-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Vss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
measure: Part F: Vss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
measure: Part G: Vss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Vss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part H: Vss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Vss of TSR-042
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
measure: Part I: Vss of TSR-022
time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
description: Blood samples were planned to be collected at indicated time points.
arm group label: Part A: TSR-042 and niraparib 200 mg QD
arm group type: Experimental
description: Patients will receive TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks [Q3W]) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks [Q6W]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
arm group label: Part A: TSR-042 and niraparib 300 mg QD
arm group type: Experimental
description: Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
arm group label: Part B: TSR-042 and carboplatin-paclitaxel
arm group type: Experimental
description: Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
arm group label: Part C: TSR-042, niraparib 200 mg QD and bevacizumab
arm group type: Experimental
description: Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
arm group label: Part C: TSR-042, niraparib 300 mg QD and bevacizumab
arm group type: Experimental
description: Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
arm group label: Part D: TSR-042, carboplatin-paclitaxel and bevacizumab
arm group type: Experimental
description: Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
arm group label: Part E: TSR-042 and carboplatin-pemetrexed
arm group type: Experimental
description: Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for 6 cycles (each cycle is 21 days).
arm group label: Part F: TSR-042, TSR-022, and carboplatin-pemetrexed
arm group type: Experimental
description: Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for 5 cycles (each cycle is 21 days); and pemetrexed 500 mg/m^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
arm group label: Part G: TSR-042 and carboplatin-nab-paclitaxel
arm group type: Experimental
description: Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (every week [Q1W]) of every 3 week cycle for 4 to 6 cycles.
arm group label: Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel
arm group type: Experimental
description: Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days) and nab-paclitaxel 100 mg/m^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
arm group label: Part I: TSR-042, TSR-022, and carboplatin-paclitaxel
arm group type: Experimental
description: Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days).
intervention type: Drug
intervention name: Niraparib
description: Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.
arm group label: Part A: TSR-042 and niraparib 200 mg QD
arm group label: Part A: TSR-042 and niraparib 300 mg QD
arm group label: Part C: TSR-042, niraparib 200 mg QD and bevacizumab
arm group label: Part C: TSR-042, niraparib 300 mg QD and bevacizumab
other name: Zejula
intervention type: Drug
intervention name: TSR-042
description: TSR-042 is a humanized monoclonal antibody that binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).
arm group label: Part A: TSR-042 and niraparib 200 mg QD
arm group label: Part A: TSR-042 and niraparib 300 mg QD
arm group label: Part B: TSR-042 and carboplatin-paclitaxel
arm group label: Part C: TSR-042, niraparib 200 mg QD and bevacizumab
arm group label: Part C: TSR-042, niraparib 300 mg QD and bevacizumab
arm group label: Part D: TSR-042, carboplatin-paclitaxel and bevacizumab
arm group label: Part E: TSR-042 and carboplatin-pemetrexed
arm group label: Part F: TSR-042, TSR-022, and carboplatin-pemetrexed
arm group label: Part G: TSR-042 and carboplatin-nab-paclitaxel
arm group label: Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel
arm group label: Part I: TSR-042, TSR-022, and carboplatin-paclitaxel
intervention type: Drug
intervention name: Carboplatin-Paclitaxel
description: Carboplatin in combination with paclitaxel is a chemotherapy treatment that has been shown to be efficacious against a variety of different tumor types, including non-small cell lung cancer [NSCLC], ovarian cancer, endometrial cancer, and head and neck cancer.
arm group label: Part B: TSR-042 and carboplatin-paclitaxel
arm group label: Part D: TSR-042, carboplatin-paclitaxel and bevacizumab
arm group label: Part I: TSR-042, TSR-022, and carboplatin-paclitaxel
intervention type: Drug
intervention name: Bevacizumab
description: Bevacizumab is a chemotherapy treatment that has been shown to be efficacious against a variety of different cancer types, including colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. Bevacizumab is in the angiogenesis inhibitor and monoclonal antibody families of medication. It works by slowing the growth of new blood vessels.
arm group label: Part C: TSR-042, niraparib 200 mg QD and bevacizumab
arm group label: Part C: TSR-042, niraparib 300 mg QD and bevacizumab
arm group label: Part D: TSR-042, carboplatin-paclitaxel and bevacizumab
other name: Avastin
intervention type: Drug
intervention name: TSR-022
description: TSR-022 is a monoclonal antibody against TIM-3 (also called HAVCR2), an immune checkpoint receptor. Immune checkpoint proteins are molecules that help to regulate the immune system so it does not mistakenly attack healthy cells. However, they can also keep immune cells from recognizing and killing cancer cells.
TIM-3 is found on the surface of certain T-cells, including tumor-infiltrating T-cells, that have left the bloodstream and migrated into the tumor environment. By binding to and blocking TIM-3, TRS-022 allows for T-cells to become activated so as to enhance T-cell-mediated attacks on tumors. These attacks reduce their growth.
arm group label: Part F: TSR-042, TSR-022, and carboplatin-pemetrexed
arm group label: Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel
arm group label: Part I: TSR-042, TSR-022, and carboplatin-paclitaxel
intervention type: Drug
intervention name: Carboplatin-Pemetrexed
description: Pemetrexed and platinum therapy in combination with pembrolizumab (anti-PD-1 antibody) has proven to be efficacious in a first line setting for nonsquamous NSCLC patients
arm group label: Part E: TSR-042 and carboplatin-pemetrexed
arm group label: Part F: TSR-042, TSR-022, and carboplatin-pemetrexed
intervention type: Drug
intervention name: Carboplatin-Nab-Paclitaxel
description: Nab-paclitaxel is a formulation of paclitaxel that is indicated for locally advanced or metastatic NSCLC, as first-line treatment in combination with carboplatin in patients who are not candidates for curative surgery or radiation therapy. Nab-paclitaxel has shown increased ORR and time to progression in metastatic breast cancer compared with solvent-based paclitaxel and has shown antitumor activity and improved ORR compared with solvent-based paclitaxel as first-line therapy in patients with NSCLC.
arm group label: Part G: TSR-042 and carboplatin-nab-paclitaxel
arm group label: Part H: TSR-042, TSR-022, and carboplatin-nab-paclitaxel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: United States
citation: Yap TA, Bessudo A, Hamilton E, Sachdev J, Patel MR, Rodon J, Evilevitch L, Duncan M, Guo W, Kumar S, Lu S, Dezube BJ, Gabrail N. IOLite: phase 1b trial of doublet/triplet combinations of dostarlimab with niraparib, carboplatin-paclitaxel, with or without bevacizumab in patients with advanced cancer. J Immunother Cancer. 2022 Mar;10(3):e003924. doi: 10.1136/jitc-2021-003924.
PMID: 35332062
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Neoplasm Metastasis
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Bevacizumab
mesh term: Carboplatin
mesh term: Pemetrexed
mesh term: Niraparib
mesh term: Dostarlimab
sharing ipd: No
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