<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/NCT03267940</url>
  </required_header>
  <id_info>
    <org_study_id>Halo-110-101</org_study_id>
    <nct_id>NCT03267940</nct_id>
  </id_info>
  <brief_title>Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma</brief_title>
  <official_title>A Phase 1B, Randomized, Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Cisplatin Plus Gemcitabine and PEGPH20 in Combination With Atezolizumab and Cisplatin Plus Gemcitabine Compared With Cisplatin Plus Gemcitabine in Subjects With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Halozyme Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Halozyme Therapeutics</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>
      The study is being conducted to assess the safety and tolerability of (1) PEGPH20 in&#xD;
      combination with CIS and GEM (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and&#xD;
      atezolizumab (PEGCISGEMATEZO) compared with (3) cisplatin and gemcitabine (CISGEM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will have a Run-in portion and an Expansion portion. The Run-in portion will be&#xD;
      used to evaluate the safety profile of the PEGCISGEM and PEGCISGEMATEZO treatments prior to&#xD;
      evaluating the efficacy and safety of PEGCISGEM and PEGCISGEMATEZO treatments compared with&#xD;
      CISGEM treatment in the Expansion portion of the study. Treatment in both portions of the&#xD;
      study will continue until death, withdrawal of consent from the study, disease progression,&#xD;
      or unacceptable toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">November 11, 2019</completion_date>
  <primary_completion_date type="Actual">November 11, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Run-in Portion: Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days)</time_frame>
    <description>An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry)</measure>
    <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)</time_frame>
    <description>Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, white blood cell [WBC] count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, blood urea nitrogen [BUN], albumin, total bilirubin, alkaline phosphatase, aspartate aminotransferase [AST], alanine aminotransferase [ALT], electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) and Vital Signs</measure>
    <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)</time_frame>
    <description>Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication</measure>
    <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)</time_frame>
    <description>Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expansion Portion: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Percentage of Participants With Objective Response</measure>
    <time_frame>From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 421 days)</time_frame>
    <description>ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Run-in Portion: ORR Based on RECIST v1.1: Percentage of Participants With Objective Response</measure>
    <time_frame>From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 508 days)</time_frame>
    <description>ORR was defined as percentage of participants who achieved either a CR or PR. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expansion Portion: Duration of Response (DOR) Based on RECIST v1.1</measure>
    <time_frame>From date of the first CR or PR until the date of first documentation of disease progression or date of death, whichever came first (maximum exposure: 421 days)</time_frame>
    <description>DOR was considered the time from date of the first CR or PR until the date of first documentation of disease progression or date of death based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expansion Portion: Progression-Free Survival (PFS) Based on RECIST v1.1</measure>
    <time_frame>From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)</time_frame>
    <description>PFS was based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review and was defined as the time from randomization to radiological disease progression or death. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on or prior to the current assessment (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of greater than or equal to (≥) 5 mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expansion Portion: Disease Control Rate (DCR) Based on RECIST v1.1: Percentage of Participants With CR, PR or Stable Disease (SD)</measure>
    <time_frame>From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)</time_frame>
    <description>DCR was defined as the percentage of participants with CR, PR, or SD based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expansion Portion: Overall Survival (OS)</measure>
    <time_frame>From randomization until death from any cause (maximum exposure: 421 days)</time_frame>
    <description>Overall survival was defined as the time from randomization until death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expansion Portion: OS by PD-L1 Expression Levels</measure>
    <time_frame>From randomization until death from any cause (maximum exposure: 421 days)</time_frame>
    <description>Overall survival was defined as the time from randomization until death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expansion Portion: Number of Participants With AEs</measure>
    <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)</time_frame>
    <description>An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expansion Portion: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters (Hematology and Blood Chemistry)</measure>
    <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)</time_frame>
    <description>Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, WBC count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, BUN, albumin, total bilirubin, alkaline phosphatase, AST, ALT, electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expansion Portion: Number of Participants With Clinically Significant Abnormalities in ECG and Vital Signs</measure>
    <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)</time_frame>
    <description>Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expansion Period: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication</measure>
    <time_frame>From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 421 days)</time_frame>
    <description>Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Run-in and Expansion Portion : Maximum Observed Plasma Concentration (Cmax) of PEGPH20, ATEZO, GEM, and CIS</measure>
    <time_frame>PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and end of treatment (EOT) (maximum exposure: 508 days for run-in and 421 days for expansion); CIS and GEM: Cycle 1: multiple timepoints on Days 2,9</time_frame>
    <description>Plasma pharmacokinetic (PK) data were planned to be analyzed using a noncompartmental analysis approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Run-in and Expansion Portion : Minimum Observed Plasma Concentration (Cmin) of PEGPH20 and ATEZO</measure>
    <time_frame>PEGPH20 and ATEZO: Treatment Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15; ATEZO: Day 1 of subsequent cycles and EOT visit (7 days after last 21-day cycle) (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)</time_frame>
    <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Run-in and Expansion Portion : Elimination Rate Constant (Kel) of PEGPH20</measure>
    <time_frame>Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15</time_frame>
    <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Run-in and Expansion Portion : Terminal Elimination Plasma Half-life (t1/2) of PEGPH20, ATEZO, GEM, and CIS</measure>
    <time_frame>PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9</time_frame>
    <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Run-in and Expansion Portion : Clearance (CL) of PEGPH20, ATEZO, GEM, and CIS</measure>
    <time_frame>PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9</time_frame>
    <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Run-in and Expansion Portion : Volume of Distribution (Vd) of PEGPH20, ATEZO, GEM, and CIS</measure>
    <time_frame>PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9</time_frame>
    <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Run-in and Expansion Portion: Area Under the Concentration Time Curve (AUC) of PEGPH20, ATEZO, GEM, and CIS</measure>
    <time_frame>PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9</time_frame>
    <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Cholangiocarcinoma Non-resectable</condition>
  <condition>Cholangiocarcinoma, Intrahepatic</condition>
  <condition>Cholangiocarcinoma, Extrahepatic</condition>
  <condition>Gallbladder Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Run-in Portion: PEGCISGEM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 3.0 micrograms per kilogram (mcg/kg) PEGPH20 on Days 1, 8, and 15 in combination with 25 milligrams per meter square (mg/m^2) of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by intravenous (IV) infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Run-in Portion: PEGCISGEMATEZO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 6 participants from the PEGCISGEM arm are treated for at least 1 cycle without significant toxicities, new participants will be enrolled in this arm to receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Portion: PEGCISGEM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After the Investigators and the Sponsor considers the study treatment with PEGCISGEM during the Run-in portion safe and tolerable, new participants will be enrolled to receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Portion: PEGCISGEMATEZO Twice Weekly</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After the Investigators and the Sponsor considers the study treatment with PEGCISGEM during the Run-in portion safe and tolerable, new participants will be enrolled to receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After the implementation of Protocol Amendment #3 and as communicated to the Investigators via a letter dated 22 March 2019, participants will receive 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants will receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Portion: CISGEM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After the Investigators and the Sponsor considers the study treatment with PEGCISGEM during the run-in portion safe and tolerable, new participants will be enrolled to receive 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEGPH20</intervention_name>
    <description>PEGPH20 will be administered as per the schedule specified in the respective arms.</description>
    <arm_group_label>Expansion Portion: PEGCISGEM</arm_group_label>
    <arm_group_label>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</arm_group_label>
    <arm_group_label>Expansion Portion: PEGCISGEMATEZO Twice Weekly</arm_group_label>
    <arm_group_label>Run-in Portion: PEGCISGEM</arm_group_label>
    <arm_group_label>Run-in Portion: PEGCISGEMATEZO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CIS</intervention_name>
    <description>CIS will be administered as per the schedule specified in the respective arms.</description>
    <arm_group_label>Expansion Portion: CISGEM</arm_group_label>
    <arm_group_label>Expansion Portion: PEGCISGEM</arm_group_label>
    <arm_group_label>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</arm_group_label>
    <arm_group_label>Expansion Portion: PEGCISGEMATEZO Twice Weekly</arm_group_label>
    <arm_group_label>Run-in Portion: PEGCISGEM</arm_group_label>
    <arm_group_label>Run-in Portion: PEGCISGEMATEZO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GEM</intervention_name>
    <description>GEM will be administered as per the schedule specified in the respective arms.</description>
    <arm_group_label>Expansion Portion: CISGEM</arm_group_label>
    <arm_group_label>Expansion Portion: PEGCISGEM</arm_group_label>
    <arm_group_label>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</arm_group_label>
    <arm_group_label>Expansion Portion: PEGCISGEMATEZO Twice Weekly</arm_group_label>
    <arm_group_label>Run-in Portion: PEGCISGEM</arm_group_label>
    <arm_group_label>Run-in Portion: PEGCISGEMATEZO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab will be administered as per the schedule specified in the respective arms.</description>
    <arm_group_label>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</arm_group_label>
    <arm_group_label>Expansion Portion: PEGCISGEMATEZO Twice Weekly</arm_group_label>
    <arm_group_label>Run-in Portion: PEGCISGEMATEZO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For both portions of the study, participants must satisfy all of the following inclusion&#xD;
        criteria to be enrolled in the study:&#xD;
&#xD;
          -  Written Institutional Review Board/Ethics Committee-approved informed consent form&#xD;
             (ICF), signed by participant or legally authorized representative.&#xD;
&#xD;
          -  Participants must be determined to have histologically confirmed unresectable, locally&#xD;
             advanced or metastatic adenocarcinoma of the intra- and/or extra-hepatic bile ducts&#xD;
             and/or gallbladder. Participants must have sufficient tissue with architectural&#xD;
             integrity, including tumor and associated stroma, available for retrospective&#xD;
             biomarker testing.&#xD;
&#xD;
          -  One or more lesions measurable on computed tomography (CT) scan/magnetic resonance&#xD;
             imaging (MRI) scan per Response Evaluation Criteria in Solid Tumors (RECIST) version&#xD;
             1.1 (v1.1).&#xD;
&#xD;
          -  Participants having Eastern Cooperative Oncology Group (ECOG) Performance Status of 0&#xD;
             to 1.&#xD;
&#xD;
          -  Life expectancy ≥3 months.&#xD;
&#xD;
          -  Males and females aged ≥18 years.&#xD;
&#xD;
          -  Screening clinical laboratory values within pre-determined parameters&#xD;
&#xD;
          -  Female participants of childbearing potential (WOCBP) must have a negative urine or&#xD;
             serum pregnancy test within 7 days before Day 1 (first dose of study medication).&#xD;
&#xD;
          -  For WOCBP and for men, agreement to use a highly effective contraceptive method from&#xD;
             the time of screening throughout the study until 5 months (WOCBP) or 6 months (men)&#xD;
             after administration of the last dose of any study medication. Highly effective&#xD;
             contraceptive methods consist of prior sterilization, intrauterine device (IUD),&#xD;
             intrauterine hormone releasing system (IUS), oral or injectable contraceptives,&#xD;
             barrier methods, and/or true sexual abstinence.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants are ineligible for enrollment if they meet any of the following exclusion&#xD;
        criteria:&#xD;
&#xD;
          -  Clinical evidence of deep vein thrombosis or pulmonary embolism present during the&#xD;
             screening period&#xD;
&#xD;
          -  New York Heart Association Class III or IV cardiac disease, atrial fibrillation,&#xD;
             unstable angina, or myocardial infarction within the past 12 months before screening.&#xD;
&#xD;
          -  Participants with known brain metastases&#xD;
&#xD;
          -  History of cerebrovascular accident or transient ischemic attack&#xD;
&#xD;
          -  History of active bleeding within the last 3 months prior to screening requiring&#xD;
             transfusion.&#xD;
&#xD;
          -  Participants must have received no previous radiotherapy, surgery, chemotherapy or&#xD;
             investigational therapy for treatment of metastatic or locally advanced disease.&#xD;
&#xD;
          -  Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs).&#xD;
&#xD;
          -  Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B&#xD;
             surface antigen (HBsAg) test at screening&#xD;
&#xD;
          -  Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody&#xD;
             test at screening&#xD;
&#xD;
          -  History of:&#xD;
&#xD;
               1. Idiopathic pulmonary fibrosis, organizing pneumonia (for example, bronchiolitis&#xD;
                  obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of&#xD;
                  active pneumonitis on screening chest CT scan. History of radiation pneumonitis&#xD;
                  in the radiation field (fibrosis) is permitted.&#xD;
&#xD;
               2. Or known cases of hepatobiliary diseases (for example, primary biliary&#xD;
                  cholangitis, primary sclerosing cholangitis, history of immune-mediated&#xD;
                  cholangitis);&#xD;
&#xD;
                  Participants with cholangitis attributed to infectious etiology (for example,&#xD;
                  ascending cholangitis, bacterial cholangitis) are eligible if the infection has&#xD;
                  been fully resolved prior to the screening visit.&#xD;
&#xD;
               3. Or known cases of drug-induced hepatobiliary toxicities.&#xD;
&#xD;
          -  Active or history of autoimmune diseases&#xD;
&#xD;
          -  Uncontrolled hypercalcemia&#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>VP, Medical, Regulatory and Drug Safety</last_name>
    <role>Study Director</role>
    <affiliation>Halozyme Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic of Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC/Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Irvine Division of Hematology-Oncology, Department of Medicine UC Irvine Health</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA - David Geffen School of Medicine</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale Cancer Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lombardi Cancer Center, Georgetown University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Institute</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Cancer Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Health Cancer Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert Hospital And Medical College</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-gu</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Guro-gu</state>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Jongno-gu</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Seocho-gu</state>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <state>Seodaemun-Gu</state>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Songpa-gu</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maharaj Nakorn Chiang Mai Hospital</name>
      <address>
        <city>Chiang mai</city>
        <state>Muang</state>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Chulalongkorn Memorial Hospital</name>
      <address>
        <city>Bangkok</city>
        <state>Patumwan</state>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Songkla University</name>
      <address>
        <city>Hat Yai</city>
        <state>Songkla</state>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
    <country>Thailand</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <results_first_submitted>January 24, 2020</results_first_submitted>
  <results_first_submitted_qc>January 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 7, 2020</results_first_posted>
  <last_update_submitted>January 24, 2020</last_update_submitted>
  <last_update_submitted_qc>January 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Extrahepatic Cholangiocarcinoma</keyword>
  <keyword>Intrahepatic Cholangiocarcinoma</keyword>
  <keyword>Gallbladder Adenocarcinoma</keyword>
  <keyword>PEGylated Recombinant Human Hyaluronidase</keyword>
  <keyword>PEGylated Recombinant Human Hyaluronidase with atezolizumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</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>April 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03267940/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted in 2 portions: Run-in portion and Expansion portion.</recruitment_details>
      <pre_assignment_details>The study was terminated prematurely by the Sponsor due to stopping the clinical development of PEGPH20 in all indications based on negative pivotal data in metastatic pancreatic cancer.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Run-in Portion: PEGCISGEM</title>
          <description>Participants received 3.0 micrograms per kilogram (mcg/kg) PEGPH20 on Days 1, 8, and 15 in combination with 25 milligrams per meter square (mg/m^2) of cisplatin (CIS) plus 1000 mg/m^2 of gemcitabine (GEM) administered on Days 2 and 9 of each 21-day cycle by intravenous (IV) infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
        </group>
        <group group_id="P2">
          <title>Run-in Portion: PEGCISGEMATEZO</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg atezolizumab (ATEZO) (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
        </group>
        <group group_id="P3">
          <title>Expansion Portion: PEGCISGEM</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
        </group>
        <group group_id="P4">
          <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
        </group>
        <group group_id="P5">
          <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
        </group>
        <group group_id="P6">
          <title>Expansion Portion: CISGEM</title>
          <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Run-in Portion (Max. Exposure: 508 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <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_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <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_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <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_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
                <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_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Investigator or Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <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_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="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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Terminated Study</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
                <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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Expansion (Maximum Exposure: 421 Days)</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="24"/>
                <participants group_id="P4" count="22"/>
                <participants group_id="P5" count="11"/>
                <participants group_id="P6" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="24"/>
                <participants group_id="P4" count="22"/>
                <participants group_id="P5" count="11"/>
                <participants group_id="P6" count="10"/>
              </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="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" 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="21"/>
                <participants group_id="P4" count="22"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other than specified</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="2"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator or Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" 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="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Terminated Study</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="4"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="3"/>
              </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="10"/>
                <participants group_id="P4" count="13"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Enrolled population included all participants enrolled in the Run-in portion and the Expansion portion of the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Run-in Portion: PEGCISGEM</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
        </group>
        <group group_id="B2">
          <title>Run-in Portion: PEGCISGEMATEZO</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
        </group>
        <group group_id="B3">
          <title>Expansion Portion: PEGCISGEM</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
        </group>
        <group group_id="B4">
          <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
        </group>
        <group group_id="B5">
          <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
        </group>
        <group group_id="B6">
          <title>Expansion Portion: CISGEM</title>
          <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
        </group>
        <group group_id="B7">
          <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="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="24"/>
            <count group_id="B4" value="22"/>
            <count group_id="B5" value="11"/>
            <count group_id="B6" value="10"/>
            <count group_id="B7" value="85"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="40"/>
                  </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="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <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="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Run-in Portion: Number of Participants With Adverse Events (AEs)</title>
        <description>An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
        <time_frame>From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days)</time_frame>
        <population>Safety population included all participants who received any study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in Portion: Number of Participants With Adverse Events (AEs)</title>
          <description>An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
          <population>Safety population included all participants who received any study medication.</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="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry)</title>
        <description>Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, white blood cell [WBC] count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, blood urea nitrogen [BUN], albumin, total bilirubin, alkaline phosphatase, aspartate aminotransferase [AST], alanine aminotransferase [ALT], electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
        <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)</time_frame>
        <population>Safety population included all participants who received any study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry)</title>
          <description>Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, white blood cell [WBC] count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, blood urea nitrogen [BUN], albumin, total bilirubin, alkaline phosphatase, aspartate aminotransferase [AST], alanine aminotransferase [ALT], electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
          <population>Safety population included all participants who received any study medication.</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="9"/>
                <count group_id="O2" value="9"/>
              </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>Primary</type>
        <title>Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) and Vital Signs</title>
        <description>Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
        <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) and Vital Signs</title>
          <description>Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication</title>
        <description>Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
        <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)</time_frame>
        <population>Safety population included all participants who received any study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication</title>
          <description>Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
          <population>Safety population included all participants who received any study medication.</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="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Expansion Portion: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Percentage of Participants With Objective Response</title>
        <description>ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
        <time_frame>From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 421 days)</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O2">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Expansion Portion: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Percentage of Participants With Objective Response</title>
          <description>ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-in Portion: ORR Based on RECIST v1.1: Percentage of Participants With Objective Response</title>
        <description>ORR was defined as percentage of participants who achieved either a CR or PR. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
        <time_frame>From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 508 days)</time_frame>
        <population>Data for this outcome measure was not Collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in Portion: ORR Based on RECIST v1.1: Percentage of Participants With Objective Response</title>
          <description>ORR was defined as percentage of participants who achieved either a CR or PR. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
          <population>Data for this outcome measure was not Collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expansion Portion: Duration of Response (DOR) Based on RECIST v1.1</title>
        <description>DOR was considered the time from date of the first CR or PR until the date of first documentation of disease progression or date of death based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
        <time_frame>From date of the first CR or PR until the date of first documentation of disease progression or date of death, whichever came first (maximum exposure: 421 days)</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O2">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Expansion Portion: Duration of Response (DOR) Based on RECIST v1.1</title>
          <description>DOR was considered the time from date of the first CR or PR until the date of first documentation of disease progression or date of death based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expansion Portion: Progression-Free Survival (PFS) Based on RECIST v1.1</title>
        <description>PFS was based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review and was defined as the time from randomization to radiological disease progression or death. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on or prior to the current assessment (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of greater than or equal to (≥) 5 mm.</description>
        <time_frame>From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O2">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Expansion Portion: Progression-Free Survival (PFS) Based on RECIST v1.1</title>
          <description>PFS was based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review and was defined as the time from randomization to radiological disease progression or death. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on or prior to the current assessment (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of greater than or equal to (≥) 5 mm.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expansion Portion: Disease Control Rate (DCR) Based on RECIST v1.1: Percentage of Participants With CR, PR or Stable Disease (SD)</title>
        <description>DCR was defined as the percentage of participants with CR, PR, or SD based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.</description>
        <time_frame>From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O2">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Expansion Portion: Disease Control Rate (DCR) Based on RECIST v1.1: Percentage of Participants With CR, PR or Stable Disease (SD)</title>
          <description>DCR was defined as the percentage of participants with CR, PR, or SD based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expansion Portion: Overall Survival (OS)</title>
        <description>Overall survival was defined as the time from randomization until death from any cause.</description>
        <time_frame>From randomization until death from any cause (maximum exposure: 421 days)</time_frame>
        <population>This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module.</population>
        <group_list>
          <group group_id="O1">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O2">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Expansion Portion: Overall Survival (OS)</title>
          <description>Overall survival was defined as the time from randomization until death from any cause.</description>
          <population>This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expansion Portion: OS by PD-L1 Expression Levels</title>
        <description>Overall survival was defined as the time from randomization until death from any cause.</description>
        <time_frame>From randomization until death from any cause (maximum exposure: 421 days)</time_frame>
        <population>This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module.</population>
        <group_list>
          <group group_id="O1">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O2">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Expansion Portion: OS by PD-L1 Expression Levels</title>
          <description>Overall survival was defined as the time from randomization until death from any cause.</description>
          <population>This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expansion Portion: Number of Participants With AEs</title>
        <description>An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
        <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)</time_frame>
        <population>Safety population included all participants who received any study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O2">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Expansion Portion: Number of Participants With AEs</title>
          <description>An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
          <population>Safety population included all participants who received any study medication.</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="24"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expansion Portion: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters (Hematology and Blood Chemistry)</title>
        <description>Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, WBC count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, BUN, albumin, total bilirubin, alkaline phosphatase, AST, ALT, electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
        <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)</time_frame>
        <population>Safety population included all participants who received any study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O2">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Expansion Portion: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters (Hematology and Blood Chemistry)</title>
          <description>Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, WBC count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, BUN, albumin, total bilirubin, alkaline phosphatase, AST, ALT, electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
          <population>Safety population included all participants who received any study medication.</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="24"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </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 group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expansion Portion: Number of Participants With Clinically Significant Abnormalities in ECG and Vital Signs</title>
        <description>Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
        <time_frame>From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O2">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Expansion Portion: Number of Participants With Clinically Significant Abnormalities in ECG and Vital Signs</title>
          <description>Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expansion Period: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication</title>
        <description>Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
        <time_frame>From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 421 days)</time_frame>
        <population>Safety population included all participants who received any study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O2">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Expansion Period: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication</title>
          <description>Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.</description>
          <population>Safety population included all participants who received any study medication.</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="24"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-in and Expansion Portion : Maximum Observed Plasma Concentration (Cmax) of PEGPH20, ATEZO, GEM, and CIS</title>
        <description>Plasma pharmacokinetic (PK) data were planned to be analyzed using a noncompartmental analysis approach.</description>
        <time_frame>PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and end of treatment (EOT) (maximum exposure: 508 days for run-in and 421 days for expansion); CIS and GEM: Cycle 1: multiple timepoints on Days 2,9</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O5">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O6">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in and Expansion Portion : Maximum Observed Plasma Concentration (Cmax) of PEGPH20, ATEZO, GEM, and CIS</title>
          <description>Plasma pharmacokinetic (PK) data were planned to be analyzed using a noncompartmental analysis approach.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-in and Expansion Portion : Minimum Observed Plasma Concentration (Cmin) of PEGPH20 and ATEZO</title>
        <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
        <time_frame>PEGPH20 and ATEZO: Treatment Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15; ATEZO: Day 1 of subsequent cycles and EOT visit (7 days after last 21-day cycle) (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O5">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O6">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in and Expansion Portion : Minimum Observed Plasma Concentration (Cmin) of PEGPH20 and ATEZO</title>
          <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-in and Expansion Portion : Elimination Rate Constant (Kel) of PEGPH20</title>
        <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
        <time_frame>Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O5">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O6">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in and Expansion Portion : Elimination Rate Constant (Kel) of PEGPH20</title>
          <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-in and Expansion Portion : Terminal Elimination Plasma Half-life (t1/2) of PEGPH20, ATEZO, GEM, and CIS</title>
        <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
        <time_frame>PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O5">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O6">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in and Expansion Portion : Terminal Elimination Plasma Half-life (t1/2) of PEGPH20, ATEZO, GEM, and CIS</title>
          <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-in and Expansion Portion : Clearance (CL) of PEGPH20, ATEZO, GEM, and CIS</title>
        <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
        <time_frame>PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O5">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O6">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in and Expansion Portion : Clearance (CL) of PEGPH20, ATEZO, GEM, and CIS</title>
          <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-in and Expansion Portion : Volume of Distribution (Vd) of PEGPH20, ATEZO, GEM, and CIS</title>
        <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
        <time_frame>PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O5">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O6">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in and Expansion Portion : Volume of Distribution (Vd) of PEGPH20, ATEZO, GEM, and CIS</title>
          <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Run-in and Expansion Portion: Area Under the Concentration Time Curve (AUC) of PEGPH20, ATEZO, GEM, and CIS</title>
        <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
        <time_frame>PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9</time_frame>
        <population>Data for this outcome measure was not collected due to early termination of study.</population>
        <group_list>
          <group group_id="O1">
            <title>Run-in Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
          </group>
          <group group_id="O2">
            <title>Run-in Portion: PEGCISGEMATEZO</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
          </group>
          <group group_id="O3">
            <title>Expansion Portion: PEGCISGEM</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
          </group>
          <group group_id="O4">
            <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
          </group>
          <group group_id="O5">
            <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
            <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
          </group>
          <group group_id="O6">
            <title>Expansion Portion: CISGEM</title>
            <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Run-in and Expansion Portion: Area Under the Concentration Time Curve (AUC) of PEGPH20, ATEZO, GEM, and CIS</title>
          <description>PK data were planned to be analyzed using a noncompartmental analysis approach.</description>
          <population>Data for this outcome measure was not collected due to early termination of study.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first exposure to study drug through 30 days after end of treatment visit (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)</time_frame>
      <desc>Safety population included all participants who received any study medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Run-in Portion: PEGCISGEM</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 190 days)</description>
        </group>
        <group group_id="E2">
          <title>Run-in Portion: PEGCISGEMATEZO</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity. (Maximum exposure: 508 days)</description>
        </group>
        <group group_id="E3">
          <title>Expansion Portion: PEGCISGEM</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 421 days).</description>
        </group>
        <group group_id="E4">
          <title>Expansion Portion: PEGCISGEMATEZO Twice Weekly</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 416 days).</description>
        </group>
        <group group_id="E5">
          <title>Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly</title>
          <description>Participants received 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants received 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 59 days).</description>
        </group>
        <group group_id="E6">
          <title>Expansion Portion: CISGEM</title>
          <description>Participants received 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment was continued until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity (Maximum exposure: 218 days).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</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="7" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Autoimmune colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Portal hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Systemic immune activation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Biliary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cholangitis infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour associated fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Renal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian necrosis</sub_title>
                <description>This is a sex-specific adverse event that only affects female participants.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </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" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.1</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="9" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eustachian tube dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Photopsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Duodenal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sensitivity of teeth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Catheter site inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vessel puncture site bruise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Portal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Catheter site cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Infected dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Febrile nonhaemolytic transfusion reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Mouth injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nail injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood fibrinogen decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood phosphorus decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood sodium increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Creatinine renal clearance decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Granulocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Grip strength decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Monocyte count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Red blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Troponin I increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypermagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Extremity contracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Trismus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Benign neoplasm of skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Emotional distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </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" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Increased upper airway secretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Prurit</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated prematurely by the Sponsor due to stopping the clinical development of PEGPH20 in all indications based on negative pivotal data in metastatic pancreatic cancer.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>VP, Medical, Regulatory and Drug Safety</name_or_title>
      <organization>Halozyme Therapeutics</organization>
      <phone>858-794-8889</phone>
      <email>medinfo@halozyme.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/NCT03267940
org study id: Halo-110-101
nct id: NCT03267940
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The study is being conducted to assess the safety and tolerability of (1) PEGPH20 in
      combination with CIS and GEM (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and
      atezolizumab (PEGCISGEMATEZO) compared with (3) cisplatin and gemcitabine (CISGEM).
The study will have a Run-in portion and an Expansion portion. The Run-in portion will be
      used to evaluate the safety profile of the PEGCISGEM and PEGCISGEMATEZO treatments prior to
      evaluating the efficacy and safety of PEGCISGEM and PEGCISGEMATEZO treatments compared with
      CISGEM treatment in the Expansion portion of the study. Treatment in both portions of the
      study will continue until death, withdrawal of consent from the study, disease progression,
      or unacceptable toxicity.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Run-in Portion: Number of Participants With Adverse Events (AEs)
time frame: From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days)
description: An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
measure: Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry)
time frame: From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)
description: Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, white blood cell [WBC] count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, blood urea nitrogen [BUN], albumin, total bilirubin, alkaline phosphatase, aspartate aminotransferase [AST], alanine aminotransferase [ALT], electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
measure: Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) and Vital Signs
time frame: From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)
description: Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
measure: Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication
time frame: From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)
description: Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
measure: Expansion Portion: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Percentage of Participants With Objective Response
time frame: From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 421 days)
description: ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
measure: Run-in Portion: ORR Based on RECIST v1.1: Percentage of Participants With Objective Response
time frame: From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 508 days)
description: ORR was defined as percentage of participants who achieved either a CR or PR. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
measure: Expansion Portion: Duration of Response (DOR) Based on RECIST v1.1
time frame: From date of the first CR or PR until the date of first documentation of disease progression or date of death, whichever came first (maximum exposure: 421 days)
description: DOR was considered the time from date of the first CR or PR until the date of first documentation of disease progression or date of death based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
measure: Expansion Portion: Progression-Free Survival (PFS) Based on RECIST v1.1
time frame: From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)
description: PFS was based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review and was defined as the time from randomization to radiological disease progression or death. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on or prior to the current assessment (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of greater than or equal to (≥) 5 mm.
measure: Expansion Portion: Disease Control Rate (DCR) Based on RECIST v1.1: Percentage of Participants With CR, PR or Stable Disease (SD)
time frame: From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)
description: DCR was defined as the percentage of participants with CR, PR, or SD based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
measure: Expansion Portion: Overall Survival (OS)
time frame: From randomization until death from any cause (maximum exposure: 421 days)
description: Overall survival was defined as the time from randomization until death from any cause.
measure: Expansion Portion: OS by PD-L1 Expression Levels
time frame: From randomization until death from any cause (maximum exposure: 421 days)
description: Overall survival was defined as the time from randomization until death from any cause.
measure: Expansion Portion: Number of Participants With AEs
time frame: From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)
description: An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
measure: Expansion Portion: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters (Hematology and Blood Chemistry)
time frame: From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)
description: Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, WBC count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, BUN, albumin, total bilirubin, alkaline phosphatase, AST, ALT, electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
measure: Expansion Portion: Number of Participants With Clinically Significant Abnormalities in ECG and Vital Signs
time frame: From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)
description: Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
measure: Expansion Period: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication
time frame: From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 421 days)
description: Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
measure: Run-in and Expansion Portion : Maximum Observed Plasma Concentration (Cmax) of PEGPH20, ATEZO, GEM, and CIS
time frame: PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and end of treatment (EOT) (maximum exposure: 508 days for run-in and 421 days for expansion); CIS and GEM: Cycle 1: multiple timepoints on Days 2,9
description: Plasma pharmacokinetic (PK) data were planned to be analyzed using a noncompartmental analysis approach.
measure: Run-in and Expansion Portion : Minimum Observed Plasma Concentration (Cmin) of PEGPH20 and ATEZO
time frame: PEGPH20 and ATEZO: Treatment Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15; ATEZO: Day 1 of subsequent cycles and EOT visit (7 days after last 21-day cycle) (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)
description: PK data were planned to be analyzed using a noncompartmental analysis approach.
measure: Run-in and Expansion Portion : Elimination Rate Constant (Kel) of PEGPH20
time frame: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15
description: PK data were planned to be analyzed using a noncompartmental analysis approach.
measure: Run-in and Expansion Portion : Terminal Elimination Plasma Half-life (t1/2) of PEGPH20, ATEZO, GEM, and CIS
time frame: PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
description: PK data were planned to be analyzed using a noncompartmental analysis approach.
measure: Run-in and Expansion Portion : Clearance (CL) of PEGPH20, ATEZO, GEM, and CIS
time frame: PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
description: PK data were planned to be analyzed using a noncompartmental analysis approach.
measure: Run-in and Expansion Portion : Volume of Distribution (Vd) of PEGPH20, ATEZO, GEM, and CIS
time frame: PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
description: PK data were planned to be analyzed using a noncompartmental analysis approach.
measure: Run-in and Expansion Portion: Area Under the Concentration Time Curve (AUC) of PEGPH20, ATEZO, GEM, and CIS
time frame: PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9
description: PK data were planned to be analyzed using a noncompartmental analysis approach.
arm group label: Run-in Portion: PEGCISGEM
arm group type: Experimental
description: Participants will receive 3.0 micrograms per kilogram (mcg/kg) PEGPH20 on Days 1, 8, and 15 in combination with 25 milligrams per meter square (mg/m^2) of CIS plus 1000 mg/m^2 of GEM administered on Days 2 and 9 of each 21-day cycle by intravenous (IV) infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
arm group label: Run-in Portion: PEGCISGEMATEZO
arm group type: Experimental
description: After 6 participants from the PEGCISGEM arm are treated for at least 1 cycle without significant toxicities, new participants will be enrolled in this arm to receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
arm group label: Expansion Portion: PEGCISGEM
arm group type: Experimental
description: After the Investigators and the Sponsor considers the study treatment with PEGCISGEM during the Run-in portion safe and tolerable, new participants will be enrolled to receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
arm group label: Expansion Portion: PEGCISGEMATEZO Twice Weekly
arm group type: Experimental
description: After the Investigators and the Sponsor considers the study treatment with PEGCISGEM during the Run-in portion safe and tolerable, new participants will be enrolled to receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
arm group label: Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
arm group type: Experimental
description: After the implementation of Protocol Amendment #3 and as communicated to the Investigators via a letter dated 22 March 2019, participants will receive 3.0 mcg/kg PEGPH20 on Days 1, 4, 8, 11, 15 and 18 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 Cycle 1) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of Cycle 1 (cycle length = 21 days) by IV infusion. Participants will receive 3.0 mcg/kg PEGPH20 on Days 1, 8, and 15 in combination with 1200 mg ATEZO (administered 1 to 3 hours after PEGPH20 on Day 1 of each 21-day cycle) plus 25 mg/m^2 of CIS and 1000 mg/m^2 GEM on Days 2 and 9 of each 21-day cycle from Cycle 2 and beyond by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
arm group label: Expansion Portion: CISGEM
arm group type: Active Comparator
description: After the Investigators and the Sponsor considers the study treatment with PEGCISGEM during the run-in portion safe and tolerable, new participants will be enrolled to receive 25 mg/m^2 CIS and 1000 mg/m^2 GEM on Days 1 and 8 of each 21-day cycle by IV infusion. Treatment will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
intervention type: Drug
intervention name: PEGPH20
description: PEGPH20 will be administered as per the schedule specified in the respective arms.
arm group label: Expansion Portion: PEGCISGEM
arm group label: Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
arm group label: Expansion Portion: PEGCISGEMATEZO Twice Weekly
arm group label: Run-in Portion: PEGCISGEM
arm group label: Run-in Portion: PEGCISGEMATEZO
intervention type: Drug
intervention name: CIS
description: CIS will be administered as per the schedule specified in the respective arms.
arm group label: Expansion Portion: CISGEM
arm group label: Expansion Portion: PEGCISGEM
arm group label: Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
arm group label: Expansion Portion: PEGCISGEMATEZO Twice Weekly
arm group label: Run-in Portion: PEGCISGEM
arm group label: Run-in Portion: PEGCISGEMATEZO
intervention type: Drug
intervention name: GEM
description: GEM will be administered as per the schedule specified in the respective arms.
arm group label: Expansion Portion: CISGEM
arm group label: Expansion Portion: PEGCISGEM
arm group label: Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
arm group label: Expansion Portion: PEGCISGEMATEZO Twice Weekly
arm group label: Run-in Portion: PEGCISGEM
arm group label: Run-in Portion: PEGCISGEMATEZO
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab will be administered as per the schedule specified in the respective arms.
arm group label: Expansion Portion: PEGCISGEMATEZO Once Weekly/Twice Weekly
arm group label: Expansion Portion: PEGCISGEMATEZO Twice Weekly
arm group label: Run-in Portion: PEGCISGEMATEZO
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: VP, Medical, Regulatory and Drug Safety
role: Study Director
affiliation: Halozyme Therapeutics
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country: Korea, Republic of
country: Thailand
country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Cholangiocarcinoma
mesh term: Atezolizumab
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated prematurely by the Sponsor due to stopping the clinical development of PEGPH20 in all indications based on negative pivotal data in metastatic pancreatic cancer.
point of contact: 