<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/NCT01704287</url>
  </required_header>
  <id_info>
    <org_study_id>P08719</org_study_id>
    <secondary_id>MK-3475-002</secondary_id>
    <secondary_id>2012-003030-17</secondary_id>
    <secondary_id>KEYNOTE-002</secondary_id>
    <secondary_id>P08719</secondary_id>
    <nct_id>NCT01704287</nct_id>
  </id_info>
  <brief_title>Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)</brief_title>
  <official_title>Randomized, Phase II Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Patients With Advanced Melanoma (KEYNOTE 002)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</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>
      This study was conducted to compare survival using pembrolizumab (SCH 900475, MK-3475) or&#xD;
      standard chemotherapy in participants with advanced melanoma (MEL) who had progressed after&#xD;
      prior therapy.&#xD;
&#xD;
      Initial Treatment Period:&#xD;
&#xD;
      Participants were initially randomized to receive either low-dose (2 mg/kg) pembrolizumab,&#xD;
      higher dose (10 mg/kg) pembrolizumab or Investigator-choice chemotherapy (ICC). The four&#xD;
      standard chemotherapy choices were: carboplatin + paclitaxel, paclitaxel alone, dacarbazine,&#xD;
      or temozolomide. The randomization to either pembrolizumab or ICC was conducted in an&#xD;
      open-label fashion.&#xD;
&#xD;
      The starting pembrolizumab dose was initially blinded to Investigators and participants until&#xD;
      Amendment 03. With Amendment 03, all ongoing pembrolizumab participants were to be treated&#xD;
      with open label, fixed dose pembrolizumab 200 mg, instead of a weight-based dosing of&#xD;
      pembrolizumab.&#xD;
&#xD;
      Switch-to-Pembrolizumab Treatment Period:&#xD;
&#xD;
      Participants who were initially randomized to receive ICC and experienced progressive disease&#xD;
      (PD) may have been eligible to switch to receiving pembrolizumab provided they met&#xD;
      protocol-specified requirements for switching. Qualified participants were re-randomized to&#xD;
      receive either pembrolizumab 2 mg/kg or pembrolizumab 10 mg/kg in a double-blind fashion.&#xD;
      Participants who qualified to switch to pembrolizumab must have completed a washout period of&#xD;
      ≥28 days from last dose of chemotherapy before receiving pembrolizumab. With Amendment 03,&#xD;
      all switched-to-pembrolizumab participants were to be treated with open-label, fixed dose&#xD;
      pembrolizumab 200 mg instead of a weight-based dosing of pembrolizumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two interim and one final statistical analyses were planned for and conducted during this&#xD;
      study:&#xD;
&#xD;
        -  Interim Analysis 1 (futility analysis),&#xD;
&#xD;
        -  Interim Analysis 2 (~18 months into study): database cutoff date 12-May-2014, and&#xD;
&#xD;
        -  Final Analysis (~36 months into study): database cutoff date 16-Nov-2015. The End of&#xD;
           Trial Analysis for the study was conducted at ~75 months into the study: database cutoff&#xD;
           date 31-Jan-2019.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2012</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">November 16, 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS) - Initial Treatment Period</measure>
    <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
    <description>PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Analysis of PFS was based on an integrated radiology and oncology (IRO) assessment and was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median PFS based on the product limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for PFS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interim Overall Survival (OS) - Initial Treatment Period</measure>
    <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
    <description>OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Final Overall Survival (OS) - Initial Treatment Period</measure>
    <time_frame>Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)</time_frame>
    <description>OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for OS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period</measure>
    <time_frame>Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)</time_frame>
    <description>OS was defined as the time from randomization to death due to any cause. Participants with an Allred Proportion Score (APS) ≥2 (membranous staining in ≥1% of cells for PD-L1) were considered to be PD-L1 Positive and participants with an APS of 0 or 1 were considered to be PD-L1 Negative. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data by PD-L1 tumor expression status is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR) - Initial Treatment Period</measure>
    <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
    <description>ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. Analysis of ORR was not planned or conducted for the switch-to-pembrolizumab treatment groups. The percentage of participants who experienced a CR or PR is presented. This was the final analysis for ORR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response (BOR) - Initial Treatment Period</measure>
    <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
    <description>BOR was assessed by independent radiology review using RECIST 1.1 and was recorded from randomization until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. BOR for the Initial Treatment Period was based on IRO. BOR for participants during the Initial Treatment Period is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response (BOR) - Switch-to-Pembrolizumab Treatment Period</measure>
    <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
    <description>The BOR was assessed using RECIST 1.1 and was recorded from the start of the second line of study drug (pembrolizumab) until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For the switch-to-pembrolizumab treatment groups, BOR was based on independent review committee (IRC) assessment. The BOR for switched-to pembrolizumab treatment groups is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) - Initial Treatment Period</measure>
    <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
    <description>For participants who demonstrated a confirmed response (Complete Response [CR]: disappearance of all target lesions or Partial Response [PR]: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. DOR analysis was based on IRO assessment. Analysis of DOR was not planned or analyzed for the switch-to-pembrolizumab treatment groups. Median DOR for participants who demonstrated a confirmed response is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced an Adverse Event (AE) - Overall Study</measure>
    <time_frame>Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)</time_frame>
    <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE. Participants were included in the treatment group in which an AE was experienced. The number of participants who experienced at least one AE is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) - Overall Study</measure>
    <time_frame>Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)</time_frame>
    <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">540</enrollment>
  <condition>Malignant Melanoma</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab 2 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg intravenously (IV) once every 3 weeks (Q3W). With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pembrolizumab 10 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Investigator-Choice Chemotherapy (ICC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICC→Pembrolizumab 2 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICC→Pembrolizumab 10 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>ICC→Pembrolizumab 10 mg/kg</arm_group_label>
    <arm_group_label>ICC→Pembrolizumab 2 mg/kg</arm_group_label>
    <arm_group_label>Pembrolizumab 10 mg/kg</arm_group_label>
    <arm_group_label>Pembrolizumab 2 mg/kg</arm_group_label>
    <other_name>SCH 900475</other_name>
    <other_name>MK-3475</other_name>
    <other_name>KEYTRUDA®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin per institutional standard</description>
    <arm_group_label>ICC→Pembrolizumab 10 mg/kg</arm_group_label>
    <arm_group_label>ICC→Pembrolizumab 2 mg/kg</arm_group_label>
    <arm_group_label>Investigator-Choice Chemotherapy (ICC)</arm_group_label>
    <other_name>PARAPLATIN®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Paclitaxel per institutional standard</description>
    <arm_group_label>ICC→Pembrolizumab 10 mg/kg</arm_group_label>
    <arm_group_label>ICC→Pembrolizumab 2 mg/kg</arm_group_label>
    <arm_group_label>Investigator-Choice Chemotherapy (ICC)</arm_group_label>
    <other_name>TAXOL®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dacarbazine</intervention_name>
    <description>Dacarbazine per institutional standard</description>
    <arm_group_label>ICC→Pembrolizumab 10 mg/kg</arm_group_label>
    <arm_group_label>ICC→Pembrolizumab 2 mg/kg</arm_group_label>
    <arm_group_label>Investigator-Choice Chemotherapy (ICC)</arm_group_label>
    <other_name>DTIC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide</intervention_name>
    <description>Temozolomide per institutional standard</description>
    <arm_group_label>ICC→Pembrolizumab 10 mg/kg</arm_group_label>
    <arm_group_label>ICC→Pembrolizumab 2 mg/kg</arm_group_label>
    <arm_group_label>Investigator-Choice Chemotherapy (ICC)</arm_group_label>
    <other_name>TEMODAR®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed diagnosis of unresectable Stage III or&#xD;
             metastatic MEL not amenable to local therapy&#xD;
&#xD;
          -  Participants must be refractory to ipilimumab&#xD;
&#xD;
          -  Participants with BRAF gene mutant melanoma must have had a prior treatment regimen&#xD;
             that included vemurafenib, dabrafenib, or an approved BRAF gene and/or&#xD;
             mitogen-activated protein kinase (MEK) protein inhibitor&#xD;
&#xD;
          -  Must consent to allow correlative studies; must provide a newly obtained tissue/biopsy&#xD;
             specimen (or specimen obtained within 60 days of consenting)&#xD;
&#xD;
          -  Radiographically measurable disease&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chemotherapy, radiation therapy, or biological cancer therapy within 4 weeks prior to&#xD;
             the first dose of study drug, or not recovered from the AEs due to cancer therapies&#xD;
             administered more than 4 weeks earlier&#xD;
&#xD;
          -  Disease progression within 24 weeks of last dose of ipilimumab&#xD;
&#xD;
          -  Participating or has participated in a study of an investigational agent or using an&#xD;
             investigational device within 30 days of the first dose of study drug&#xD;
&#xD;
          -  Expected to require any other form of systemic or localized antineoplastic therapy&#xD;
             while on study&#xD;
&#xD;
          -  Chronic systemic steroid therapy within 2 weeks before the planned date for first dose&#xD;
             randomized treatment or on any other form of immunosuppressive medication&#xD;
&#xD;
          -  Known history of any other than the current malignancy excepting adequately treated&#xD;
             basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ&#xD;
             cervical cancer, breast cancer, or other in situ cancers&#xD;
&#xD;
          -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis&#xD;
&#xD;
          -  Active autoimmune disease or a history of autoimmune disease or syndrome that requires&#xD;
             systemic steroids or immunosuppressive agents&#xD;
&#xD;
          -  Prior treatment with any other anti-programmed cell death (PD) agent&#xD;
&#xD;
          -  Active infection requiring systemic therapy&#xD;
&#xD;
          -  Known history of Human Immunodeficiency Virus (HIV)&#xD;
&#xD;
          -  Active Hepatitis B or Hepatitis C&#xD;
&#xD;
          -  Regular user (including recreational use of) illicit drugs or had a recent history&#xD;
             (within the last year) of substance abuse (including alcohol)&#xD;
&#xD;
          -  Pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the study through 120 days after last dose of study drug&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://merckoncologyclinicaltrials.com</url>
    <description>Merck Oncology Clinical Trials Information</description>
  </link>
  <reference>
    <citation>Ribas A, Puzanov I, Dummer R, Schadendorf D, Hamid O, Robert C, Hodi FS, Schachter J, Pavlick AC, Lewis KD, Cranmer LD, Blank CU, O'Day SJ, Ascierto PA, Salama AK, Margolin KA, Loquai C, Eigentler TK, Gangadhar TC, Carlino MS, Agarwala SS, Moschos SJ, Sosman JA, Goldinger SM, Shapira-Frommer R, Gonzalez R, Kirkwood JM, Wolchok JD, Eggermont A, Li XN, Zhou W, Zernhelt AM, Lis J, Ebbinghaus S, Kang SP, Daud A. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):908-18. doi: 10.1016/S1470-2045(15)00083-2. Epub 2015 Jun 23.</citation>
    <PMID>26115796</PMID>
  </reference>
  <results_reference>
    <citation>Hamid O, Puzanov I, Dummer R, Schachter J, Daud A, Schadendorf D, Blank C, Cranmer LD, Robert C, Pavlick AC, Gonzalez R, Hodi FS, Ascierto PA, Salama AKS, Margolin KA, Gangadhar TC, Wei Z, Ebbinghaus S, Ibrahim N, Ribas A. Final analysis of a randomised trial comparing pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory advanced melanoma. Eur J Cancer. 2017 Nov;86:37-45. doi: 10.1016/j.ejca.2017.07.022.</citation>
    <PMID>28961465</PMID>
  </results_reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <results_first_submitted>October 17, 2016</results_first_submitted>
  <results_first_submitted_qc>February 8, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 28, 2017</results_first_posted>
  <last_update_submitted>April 29, 2020</last_update_submitted>
  <last_update_submitted_qc>April 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Programmed Cell Death-1 (PD1, PD-1)</keyword>
  <keyword>Programmed Death-Ligand 1 (PDL1, PD-L1)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Temozolomide</mesh_term>
    <mesh_term>Dacarbazine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This end of trial analysis is based on a trial closure database cutoff date of 31-Jan-2019.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pembrolizumab 2 mg/kg</title>
          <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg intravenously (IV) once every 3 weeks (Q3W). With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="P2">
          <title>Pembrolizumab 10 mg/kg</title>
          <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="P3">
          <title>Investigator-Choice Chemotherapy (ICC)</title>
          <description>Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="P4">
          <title>ICC→Pembrolizumab 2 mg/kg</title>
          <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="P5">
          <title>ICC→Pembrolizumab 10 mg/kg</title>
          <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Initial Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="180"/>
                <participants group_id="P2" count="181"/>
                <participants group_id="P3" count="179"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="178"/>
                <participants group_id="P2" count="179"/>
                <participants group_id="P3" count="171"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="47"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="134"/>
                <participants group_id="P3" count="173"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
                <participants group_id="P2" count="129"/>
                <participants group_id="P3" count="71"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Switched to Pembrolizumab</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="98"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Switch to Pembrolizumab Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="53"/>
                <participants group_id="P5" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="15"/>
                <participants group_id="P5" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="38"/>
                <participants group_id="P5" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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="2"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="35"/>
                <participants group_id="P5" count="37"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis population consisted of all randomized participants. Participants were included in the group to which they were initially randomized for Baseline Characteristics.</population>
      <group_list>
        <group group_id="B1">
          <title>Pembrolizumab 2 mg/kg</title>
          <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="B2">
          <title>Pembrolizumab 10 mg/kg</title>
          <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="B3">
          <title>Investigator-Choice Chemotherapy (ICC)</title>
          <description>Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="B4">
          <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="180"/>
            <count group_id="B2" value="181"/>
            <count group_id="B3" value="179"/>
            <count group_id="B4" value="540"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.5" spread="14.9"/>
                    <measurement group_id="B2" value="60.1" spread="13.3"/>
                    <measurement group_id="B3" value="60.5" spread="12.7"/>
                    <measurement group_id="B4" value="60.1" spread="13.6"/>
                  </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="76"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="213"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="114"/>
                    <measurement group_id="B4" value="327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status</title>
          <description>Membranous PD-L1 expression in tumor and tumor-associated immune cells was assessed by immunohistochemistry assay and scored on a unique melanoma (Allred Proportion Score [APS]/Melanoma [MEL]) scale of 0 to 5 points. Participants with an APS score of ≥2 (membranous staining in ≥1% of cells) were considered to be PD-L1 Positive and participants with an APS score of 0 or 1 were considered to be PD-L1 Negative.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>PD-L1 Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="98"/>
                    <measurement group_id="B4" value="294"/>
                  </measurement_list>
                </category>
                <category>
                  <title>PD-L1 Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival (PFS) - Initial Treatment Period</title>
        <description>PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Analysis of PFS was based on an integrated radiology and oncology (IRO) assessment and was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median PFS based on the product limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for PFS.</description>
        <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
        <population>The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 2 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab 10 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O3">
            <title>Investigator-Choice Chemotherapy (ICC)</title>
            <description>Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) - Initial Treatment Period</title>
          <description>PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Analysis of PFS was based on an integrated radiology and oncology (IRO) assessment and was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median PFS based on the product limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for PFS.</description>
          <population>The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="2.8" upper_limit="3.8"/>
                    <measurement group_id="O2" value="3.0" lower_limit="2.8" upper_limit="5.2"/>
                    <measurement group_id="O3" value="2.8" lower_limit="2.6" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <non_inferiority_desc>Cox regression model with treatment as covariate stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1); lactate dehydrogenase (LDH) levels (normal vs. elevated LDH levels [≥110% Upper Limit of Normal (ULN)]); &amp; BRAF mutational status (mutant vs. wild-type)</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>One-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>0.73</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 2 mg/kg Denominator=ICC</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <non_inferiority_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>One-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.37</ci_lower_limit>
            <ci_upper_limit>0.60</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 10 mg/kg Denominator=ICC</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <non_inferiority_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</non_inferiority_desc>
            <p_value>0.1247</p_value>
            <p_value_desc>Two-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Interim Overall Survival (OS) - Initial Treatment Period</title>
        <description>OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS.</description>
        <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
        <population>The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 2 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab 10 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O3">
            <title>Investigator-Choice Chemotherapy (ICC)</title>
            <description>Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Interim Overall Survival (OS) - Initial Treatment Period</title>
          <description>OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS.</description>
          <population>The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4" lower_limit="11.0" upper_limit="16.4"/>
                    <measurement group_id="O2" value="14.7" lower_limit="11.3" upper_limit="19.5"/>
                    <measurement group_id="O3" value="11.0" lower_limit="8.9" upper_limit="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1173</p_value>
            <p_value_desc>One-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 2 mg/kg Denominator=ICC</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0106</p_value>
            <p_value_desc>One-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 10 mg/kg Denominator=ICC</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.2905</p_value>
            <p_value_desc>Two-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Final Overall Survival (OS) - Initial Treatment Period</title>
        <description>OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for OS.</description>
        <time_frame>Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)</time_frame>
        <population>The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 2 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab 10 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O3">
            <title>Investigator-Choice Chemotherapy (ICC)</title>
            <description>Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Final Overall Survival (OS) - Initial Treatment Period</title>
          <description>OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for OS.</description>
          <population>The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4" lower_limit="11.0" upper_limit="16.4"/>
                    <measurement group_id="O2" value="14.7" lower_limit="11.3" upper_limit="19.5"/>
                    <measurement group_id="O3" value="11.0" lower_limit="8.9" upper_limit="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1146</p_value>
            <p_value_desc>One-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 2 mg/kg Denominator=ICC</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0023</p_value>
            <p_value_desc>One-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 10 mg/kg Denominator=ICC</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1490</p_value>
            <p_value_desc>Two-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period</title>
        <description>OS was defined as the time from randomization to death due to any cause. Participants with an Allred Proportion Score (APS) ≥2 (membranous staining in ≥1% of cells for PD-L1) were considered to be PD-L1 Positive and participants with an APS of 0 or 1 were considered to be PD-L1 Negative. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data by PD-L1 tumor expression status is presented.</description>
        <time_frame>Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)</time_frame>
        <population>The analysis population consisted of all randomized participants who had a PD-L1 tumor expression status assessment. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 2 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab 10 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O3">
            <title>Investigator-Choice Chemotherapy (ICC)</title>
            <description>Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period</title>
          <description>OS was defined as the time from randomization to death due to any cause. Participants with an Allred Proportion Score (APS) ≥2 (membranous staining in ≥1% of cells for PD-L1) were considered to be PD-L1 Positive and participants with an APS of 0 or 1 were considered to be PD-L1 Negative. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data by PD-L1 tumor expression status is presented.</description>
          <population>The analysis population consisted of all randomized participants who had a PD-L1 tumor expression status assessment. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PD-L1 Positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.9" upper_limit="20.9"/>
                    <measurement group_id="O2" value="17.5" lower_limit="13.7" upper_limit="28.9"/>
                    <measurement group_id="O3" value="12.1" lower_limit="7.7" upper_limit="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD-L1 Negative</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" lower_limit="6.4" upper_limit="13.5"/>
                    <measurement group_id="O2" value="13.4" lower_limit="4.6" upper_limit="23.3"/>
                    <measurement group_id="O3" value="9.3" lower_limit="5.1" upper_limit="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <non_inferiority_desc>PD-L1-Positive Participants</non_inferiority_desc>
            <p_value>0.3113</p_value>
            <p_value_desc>One-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 2 mg/kg Denominator=ICC</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <non_inferiority_desc>PD-L1 Positive Participants</non_inferiority_desc>
            <p_value>0.0208</p_value>
            <p_value_desc>One-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 10 mg/kg Denominator=ICC</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <non_inferiority_desc>PD-L1 Positive Participants</non_inferiority_desc>
            <p_value>0.0496</p_value>
            <p_value_desc>Two-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <non_inferiority_desc>PD-L1 Negative Participants</non_inferiority_desc>
            <p_value>0.6043</p_value>
            <p_value_desc>One-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 2 mg/kg Denominator=ICC</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <non_inferiority_desc>PD-L1 Negative Participants</non_inferiority_desc>
            <p_value>0.0335</p_value>
            <p_value_desc>One-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.37</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 10 mg/kg Denominator=ICC</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); &amp; BRAF mutational status (mutant vs. wild-type)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <non_inferiority_desc>PD-L1 Negative Participants</non_inferiority_desc>
            <p_value>0.1504</p_value>
            <p_value_desc>Two-sided p-value based on stratified log rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>1.13</ci_upper_limit>
            <estimate_desc>Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR) - Initial Treatment Period</title>
        <description>ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. Analysis of ORR was not planned or conducted for the switch-to-pembrolizumab treatment groups. The percentage of participants who experienced a CR or PR is presented. This was the final analysis for ORR.</description>
        <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
        <population>The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 2 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab 10 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O3">
            <title>Investigator-Choice Chemotherapy (ICC)</title>
            <description>Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR) - Initial Treatment Period</title>
          <description>ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. Analysis of ORR was not planned or conducted for the switch-to-pembrolizumab treatment groups. The percentage of participants who experienced a CR or PR is presented. This was the final analysis for ORR.</description>
          <population>The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" lower_limit="16.4" upper_limit="29.0"/>
                    <measurement group_id="O2" value="27.6" lower_limit="21.3" upper_limit="34.7"/>
                    <measurement group_id="O3" value="4.5" lower_limit="1.9" upper_limit="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Response (BOR) - Initial Treatment Period</title>
        <description>BOR was assessed by independent radiology review using RECIST 1.1 and was recorded from randomization until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. BOR for the Initial Treatment Period was based on IRO. BOR for participants during the Initial Treatment Period is presented.</description>
        <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
        <population>The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 2 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab 10 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O3">
            <title>Investigator-Choice Chemotherapy (ICC)</title>
            <description>Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Response (BOR) - Initial Treatment Period</title>
          <description>BOR was assessed by independent radiology review using RECIST 1.1 and was recorded from randomization until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. BOR for the Initial Treatment Period was based on IRO. BOR for participants during the Initial Treatment Period is presented.</description>
          <population>The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="181"/>
                <count group_id="O3" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="16.4" upper_limit="29.0"/>
                    <measurement group_id="O2" value="7.2" lower_limit="21.3" upper_limit="34.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="1.9" upper_limit="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9"/>
                    <measurement group_id="O2" value="20.4"/>
                    <measurement group_id="O3" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                    <measurement group_id="O2" value="14.9"/>
                    <measurement group_id="O3" value="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7"/>
                    <measurement group_id="O2" value="47.5"/>
                    <measurement group_id="O3" value="61.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Evaluable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3"/>
                    <measurement group_id="O2" value="9.9"/>
                    <measurement group_id="O3" value="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Response (BOR) - Switch-to-Pembrolizumab Treatment Period</title>
        <description>The BOR was assessed using RECIST 1.1 and was recorded from the start of the second line of study drug (pembrolizumab) until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For the switch-to-pembrolizumab treatment groups, BOR was based on independent review committee (IRC) assessment. The BOR for switched-to pembrolizumab treatment groups is presented.</description>
        <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
        <population>The analysis population consisted of all randomized participants in ICC who switched to receiving pembrolizumab. Participants were included in the treatment group to which they were re-randomized (switched) for this efficacy analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>ICC→Pembrolizumab 2 mg/kg</title>
            <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O2">
            <title>ICC→Pembrolizumab 10 mg/kg</title>
            <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Response (BOR) - Switch-to-Pembrolizumab Treatment Period</title>
          <description>The BOR was assessed using RECIST 1.1 and was recorded from the start of the second line of study drug (pembrolizumab) until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For the switch-to-pembrolizumab treatment groups, BOR was based on independent review committee (IRC) assessment. The BOR for switched-to pembrolizumab treatment groups is presented.</description>
          <population>The analysis population consisted of all randomized participants in ICC who switched to receiving pembrolizumab. Participants were included in the treatment group to which they were re-randomized (switched) for this efficacy analysis.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                    <measurement group_id="O2" value="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.0"/>
                    <measurement group_id="O2" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1"/>
                    <measurement group_id="O2" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.7"/>
                    <measurement group_id="O2" value="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Evaluable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3"/>
                    <measurement group_id="O2" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) - Initial Treatment Period</title>
        <description>For participants who demonstrated a confirmed response (Complete Response [CR]: disappearance of all target lesions or Partial Response [PR]: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. DOR analysis was based on IRO assessment. Analysis of DOR was not planned or analyzed for the switch-to-pembrolizumab treatment groups. Median DOR for participants who demonstrated a confirmed response is presented.</description>
        <time_frame>Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)</time_frame>
        <population>The analysis population consisted of all randomized participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 2 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab 10 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O3">
            <title>Investigator-Choice Chemotherapy (ICC)</title>
            <description>Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) - Initial Treatment Period</title>
          <description>For participants who demonstrated a confirmed response (Complete Response [CR]: disappearance of all target lesions or Partial Response [PR]: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. DOR analysis was based on IRO assessment. Analysis of DOR was not planned or analyzed for the switch-to-pembrolizumab treatment groups. Median DOR for participants who demonstrated a confirmed response is presented.</description>
          <population>The analysis population consisted of all randomized participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" lower_limit="1.4" upper_limit="25.3"/>
                    <measurement group_id="O2" value="NA" lower_limit="1.1" upper_limit="NA">NA=DOR Median not reached NA=DOR Upper Limit not reached: no progressive disease by time of last assessment</measurement>
                    <measurement group_id="O3" value="6.8" lower_limit="2.8" upper_limit="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced an Adverse Event (AE) - Overall Study</title>
        <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE. Participants were included in the treatment group in which an AE was experienced. The number of participants who experienced at least one AE is presented.</description>
        <time_frame>Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)</time_frame>
        <population>The analysis population consisted of all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 2 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab 10 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O3">
            <title>ICC Only</title>
            <description>Participants were randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O4">
            <title>ICC→Pembrolizumab 2 mg/kg</title>
            <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O5">
            <title>ICC→Pembrolizumab 10 mg/kg</title>
            <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O6">
            <title>ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab)</title>
            <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O7">
            <title>ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab)</title>
            <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced an Adverse Event (AE) - Overall Study</title>
          <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE. Participants were included in the treatment group in which an AE was experienced. The number of participants who experienced at least one AE is presented.</description>
          <population>The analysis population consisted of all participants who received at least one dose of study drug.</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="178"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="73"/>
                <count group_id="O4" value="53"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="53"/>
                <count group_id="O7" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="172"/>
                    <measurement group_id="O2" value="179"/>
                    <measurement group_id="O3" value="71"/>
                    <measurement group_id="O4" value="52"/>
                    <measurement group_id="O5" value="45"/>
                    <measurement group_id="O6" value="53"/>
                    <measurement group_id="O7" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) - Overall Study</title>
        <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented.</description>
        <time_frame>Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)</time_frame>
        <population>The analysis population consisted of all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab 2 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab 10 mg/kg</title>
            <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O3">
            <title>ICC Only</title>
            <description>Participants were randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O4">
            <title>ICC→Pembrolizumab 2 mg/kg</title>
            <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O5">
            <title>ICC→Pembrolizumab 10 mg/kg</title>
            <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O6">
            <title>ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab)</title>
            <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
          </group>
          <group group_id="O7">
            <title>ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab)</title>
            <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) - Overall Study</title>
          <description>An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented.</description>
          <population>The analysis population consisted of all participants who received at least one dose of study drug.</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="178"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="73"/>
                <count group_id="O4" value="53"/>
                <count group_id="O5" value="45"/>
                <count group_id="O6" value="53"/>
                <count group_id="O7" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)</time_frame>
      <desc>Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms &quot;Neoplasm progression&quot;, &quot;Malignant neoplasm progression&quot; and &quot;Disease progression&quot; not related to study drug are excluded as AEs.</desc>
      <group_list>
        <group group_id="E1">
          <title>Investigator-Choice Chemotherapy (ICC) Only</title>
          <description>Participants received 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the final analysis. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="E2">
          <title>ICC→Pembrolizumab 2 mg/kg (Before Switch to Pembrolizumab)</title>
          <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="E3">
          <title>ICC→Pembrolizumab 10 mg/kg (Before Switch to Pembrolizumab)</title>
          <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="E4">
          <title>Pembrolizumab 2 mg/kg</title>
          <description>Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="E5">
          <title>Pembrolizumab 10 mg/kg</title>
          <description>Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="E6">
          <title>ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab)</title>
          <description>Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
        </group>
        <group group_id="E7">
          <title>ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab)</title>
          <description>Participants who were initiall randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</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="71" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="139" subjects_at_risk="178"/>
                <counts group_id="E5" subjects_affected="129" subjects_at_risk="179"/>
                <counts group_id="E6" subjects_affected="35" subjects_at_risk="53"/>
                <counts group_id="E7" subjects_affected="37" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="53"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="91" subjects_at_risk="178"/>
                <counts group_id="E5" subjects_affected="78" subjects_at_risk="179"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="53"/>
                <counts group_id="E7" subjects_affected="18" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cardiac ventricular disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Addison's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Adrenocortical insufficiency acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypopituitarism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Secondary adrenocortical insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye movement disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Iritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Autoimmune colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Gastric disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Intussusception</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Large intestinal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Malabsorption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Small intestinal perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hepatic necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="5" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cellulitis streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Enterocolitis infectious</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Infected cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Mastitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pelvic abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Streptococcal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Fracture displacement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Radiation necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Traumatic intracranial haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Osteolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cervical spine stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Intracranial tumour haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Colon cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Intestinal metastasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Metastases to lymph nodes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Metastases to meninges</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Metastasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Oncologic complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Small cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Meningitis noninfective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Myasthenic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Myoclonus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Partial seizures</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Postrenal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Laryngeal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pulmonary thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Alveolitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Lichenoid keratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Skin mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Stevens-Johnson syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Poor venous access</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</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="66" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="53"/>
                <counts group_id="E3" subjects_affected="44" subjects_at_risk="45"/>
                <counts group_id="E4" subjects_affected="158" subjects_at_risk="178"/>
                <counts group_id="E5" subjects_affected="176" subjects_at_risk="179"/>
                <counts group_id="E6" subjects_affected="48" subjects_at_risk="53"/>
                <counts group_id="E7" subjects_affected="36" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="26" subjects_affected="21" subjects_at_risk="73"/>
                <counts group_id="E2" events="25" subjects_affected="15" subjects_at_risk="53"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="45"/>
                <counts group_id="E4" events="43" subjects_affected="30" subjects_at_risk="178"/>
                <counts group_id="E5" events="31" subjects_affected="26" subjects_at_risk="179"/>
                <counts group_id="E6" events="13" subjects_affected="12" subjects_at_risk="53"/>
                <counts group_id="E7" events="21" subjects_affected="8" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="7" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="14" subjects_affected="7" subjects_at_risk="53"/>
                <counts group_id="E3" events="8" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="73"/>
                <counts group_id="E2" events="10" subjects_affected="7" subjects_at_risk="53"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E5" events="5" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="8" subjects_affected="4" subjects_at_risk="178"/>
                <counts group_id="E5" events="11" subjects_affected="10" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="17" subjects_affected="16" subjects_at_risk="178"/>
                <counts group_id="E5" events="16" subjects_affected="15" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" events="38" subjects_affected="28" subjects_at_risk="178"/>
                <counts group_id="E5" events="33" subjects_affected="27" subjects_at_risk="179"/>
                <counts group_id="E6" events="7" subjects_affected="7" subjects_at_risk="53"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="19" subjects_affected="16" subjects_at_risk="73"/>
                <counts group_id="E2" events="17" subjects_affected="12" subjects_at_risk="53"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="45"/>
                <counts group_id="E4" events="47" subjects_affected="40" subjects_at_risk="178"/>
                <counts group_id="E5" events="57" subjects_affected="42" subjects_at_risk="179"/>
                <counts group_id="E6" events="14" subjects_affected="12" subjects_at_risk="53"/>
                <counts group_id="E7" events="6" subjects_affected="6" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="20" subjects_affected="13" subjects_at_risk="73"/>
                <counts group_id="E2" events="17" subjects_affected="11" subjects_at_risk="53"/>
                <counts group_id="E3" events="17" subjects_affected="11" subjects_at_risk="45"/>
                <counts group_id="E4" events="52" subjects_affected="40" subjects_at_risk="178"/>
                <counts group_id="E5" events="67" subjects_affected="41" subjects_at_risk="179"/>
                <counts group_id="E6" events="23" subjects_affected="16" subjects_at_risk="53"/>
                <counts group_id="E7" events="22" subjects_affected="9" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="30" subjects_affected="23" subjects_at_risk="73"/>
                <counts group_id="E2" events="44" subjects_affected="29" subjects_at_risk="53"/>
                <counts group_id="E3" events="23" subjects_affected="19" subjects_at_risk="45"/>
                <counts group_id="E4" events="74" subjects_affected="44" subjects_at_risk="178"/>
                <counts group_id="E5" events="56" subjects_affected="49" subjects_at_risk="179"/>
                <counts group_id="E6" events="12" subjects_affected="12" subjects_at_risk="53"/>
                <counts group_id="E7" events="17" subjects_affected="10" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="22" subjects_affected="17" subjects_at_risk="73"/>
                <counts group_id="E2" events="14" subjects_affected="10" subjects_at_risk="53"/>
                <counts group_id="E3" events="14" subjects_affected="13" subjects_at_risk="45"/>
                <counts group_id="E4" events="26" subjects_affected="19" subjects_at_risk="178"/>
                <counts group_id="E5" events="58" subjects_affected="38" subjects_at_risk="179"/>
                <counts group_id="E6" events="7" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="13" subjects_affected="11" subjects_at_risk="178"/>
                <counts group_id="E5" events="10" subjects_affected="9" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="178"/>
                <counts group_id="E5" events="12" subjects_affected="12" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="11" subjects_affected="9" subjects_at_risk="178"/>
                <counts group_id="E5" events="10" subjects_affected="7" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" events="25" subjects_affected="19" subjects_at_risk="178"/>
                <counts group_id="E5" events="44" subjects_affected="20" subjects_at_risk="179"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="34" subjects_affected="28" subjects_at_risk="73"/>
                <counts group_id="E2" events="36" subjects_affected="27" subjects_at_risk="53"/>
                <counts group_id="E3" events="33" subjects_affected="26" subjects_at_risk="45"/>
                <counts group_id="E4" events="106" subjects_affected="74" subjects_at_risk="178"/>
                <counts group_id="E5" events="117" subjects_affected="91" subjects_at_risk="179"/>
                <counts group_id="E6" events="17" subjects_affected="15" subjects_at_risk="53"/>
                <counts group_id="E7" events="24" subjects_affected="16" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="13" subjects_affected="9" subjects_at_risk="178"/>
                <counts group_id="E5" events="17" subjects_affected="14" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E7" events="6" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="19" subjects_affected="17" subjects_at_risk="178"/>
                <counts group_id="E5" events="24" subjects_affected="21" subjects_at_risk="179"/>
                <counts group_id="E6" events="7" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="178"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="179"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="73"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E4" events="33" subjects_affected="23" subjects_at_risk="178"/>
                <counts group_id="E5" events="43" subjects_affected="30" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="8" subjects_affected="8" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="178"/>
                <counts group_id="E5" events="15" subjects_affected="11" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E4" events="11" subjects_affected="10" subjects_at_risk="178"/>
                <counts group_id="E5" events="13" subjects_affected="11" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="9" subjects_affected="7" subjects_at_risk="178"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="11" subjects_affected="10" subjects_at_risk="178"/>
                <counts group_id="E5" events="36" subjects_affected="20" subjects_at_risk="179"/>
                <counts group_id="E6" events="9" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" events="12" subjects_affected="8" subjects_at_risk="178"/>
                <counts group_id="E5" events="25" subjects_affected="18" subjects_at_risk="179"/>
                <counts group_id="E6" events="6" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" events="19" subjects_affected="17" subjects_at_risk="178"/>
                <counts group_id="E5" events="23" subjects_affected="17" subjects_at_risk="179"/>
                <counts group_id="E6" events="8" subjects_affected="8" subjects_at_risk="53"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="178"/>
                <counts group_id="E5" events="18" subjects_affected="13" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="4" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="178"/>
                <counts group_id="E5" events="17" subjects_affected="14" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" events="13" subjects_affected="12" subjects_at_risk="178"/>
                <counts group_id="E5" events="16" subjects_affected="10" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="178"/>
                <counts group_id="E5" events="17" subjects_affected="17" subjects_at_risk="179"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="11" subjects_affected="6" subjects_at_risk="178"/>
                <counts group_id="E5" events="5" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="9" subjects_affected="5" subjects_at_risk="178"/>
                <counts group_id="E5" events="14" subjects_affected="7" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" events="17" subjects_affected="6" subjects_at_risk="178"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" events="10" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="5" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E2" events="9" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="8" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E4" events="9" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="9" subjects_affected="5" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="12" subjects_affected="4" subjects_at_risk="178"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="7" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="21" subjects_affected="20" subjects_at_risk="73"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="53"/>
                <counts group_id="E3" events="12" subjects_affected="11" subjects_at_risk="45"/>
                <counts group_id="E4" events="43" subjects_affected="36" subjects_at_risk="178"/>
                <counts group_id="E5" events="55" subjects_affected="51" subjects_at_risk="179"/>
                <counts group_id="E6" events="9" subjects_affected="9" subjects_at_risk="53"/>
                <counts group_id="E7" events="8" subjects_affected="8" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="9" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="21" subjects_affected="12" subjects_at_risk="178"/>
                <counts group_id="E5" events="21" subjects_affected="11" subjects_at_risk="179"/>
                <counts group_id="E6" events="7" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="178"/>
                <counts group_id="E5" events="10" subjects_affected="8" subjects_at_risk="179"/>
                <counts group_id="E6" events="7" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" events="28" subjects_affected="19" subjects_at_risk="178"/>
                <counts group_id="E5" events="11" subjects_affected="10" subjects_at_risk="179"/>
                <counts group_id="E6" events="11" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="7" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="15" subjects_affected="7" subjects_at_risk="178"/>
                <counts group_id="E5" events="7" subjects_affected="6" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E4" events="18" subjects_affected="7" subjects_at_risk="178"/>
                <counts group_id="E5" events="25" subjects_affected="10" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="178"/>
                <counts group_id="E5" events="13" subjects_affected="12" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E4" events="52" subjects_affected="36" subjects_at_risk="178"/>
                <counts group_id="E5" events="37" subjects_affected="24" subjects_at_risk="179"/>
                <counts group_id="E6" events="13" subjects_affected="9" subjects_at_risk="53"/>
                <counts group_id="E7" events="9" subjects_affected="8" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E4" events="31" subjects_affected="24" subjects_at_risk="178"/>
                <counts group_id="E5" events="27" subjects_affected="21" subjects_at_risk="179"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="20" subjects_affected="18" subjects_at_risk="178"/>
                <counts group_id="E5" events="15" subjects_affected="15" subjects_at_risk="179"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="7" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" events="23" subjects_affected="19" subjects_at_risk="178"/>
                <counts group_id="E5" events="15" subjects_affected="14" subjects_at_risk="179"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E4" events="25" subjects_affected="18" subjects_at_risk="178"/>
                <counts group_id="E5" events="25" subjects_affected="19" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E7" events="4" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="10" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="45"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="178"/>
                <counts group_id="E5" events="11" subjects_affected="9" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="6" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Melanocytic naevus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="5" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="25" subjects_affected="19" subjects_at_risk="178"/>
                <counts group_id="E5" events="27" subjects_affected="18" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="7" subjects_affected="7" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="53"/>
                <counts group_id="E3" events="10" subjects_affected="7" subjects_at_risk="45"/>
                <counts group_id="E4" events="33" subjects_affected="21" subjects_at_risk="178"/>
                <counts group_id="E5" events="45" subjects_affected="30" subjects_at_risk="179"/>
                <counts group_id="E6" events="11" subjects_affected="8" subjects_at_risk="53"/>
                <counts group_id="E7" events="10" subjects_affected="6" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="45"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="53"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="45"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="178"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="73"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="178"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="178"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="178"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="179"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="178"/>
                <counts group_id="E5" events="12" subjects_affected="11" subjects_at_risk="179"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="178"/>
                <counts group_id="E5" events="13" subjects_affected="12" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="73"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="53"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E4" events="50" subjects_affected="37" subjects_at_risk="178"/>
                <counts group_id="E5" events="50" subjects_affected="42" subjects_at_risk="179"/>
                <counts group_id="E6" events="7" subjects_affected="7" subjects_at_risk="53"/>
                <counts group_id="E7" events="6" subjects_affected="5" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="73"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="20" subjects_affected="18" subjects_at_risk="178"/>
                <counts group_id="E5" events="33" subjects_affected="29" subjects_at_risk="179"/>
                <counts group_id="E6" events="7" subjects_affected="7" subjects_at_risk="53"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="178"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="178"/>
                <counts group_id="E5" events="11" subjects_affected="10" subjects_at_risk="179"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="73"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="45"/>
                <counts group_id="E4" events="77" subjects_affected="49" subjects_at_risk="178"/>
                <counts group_id="E5" events="74" subjects_affected="57" subjects_at_risk="179"/>
                <counts group_id="E6" events="7" subjects_affected="6" subjects_at_risk="53"/>
                <counts group_id="E7" events="5" subjects_affected="5" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="45"/>
                <counts group_id="E4" events="38" subjects_affected="29" subjects_at_risk="178"/>
                <counts group_id="E5" events="49" subjects_affected="33" subjects_at_risk="179"/>
                <counts group_id="E6" events="15" subjects_affected="11" subjects_at_risk="53"/>
                <counts group_id="E7" events="9" subjects_affected="7" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="11" subjects_affected="10" subjects_at_risk="178"/>
                <counts group_id="E5" events="23" subjects_affected="18" subjects_at_risk="179"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="73"/>
                <counts group_id="E2" events="18" subjects_affected="15" subjects_at_risk="53"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="45"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="178"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="24" subjects_affected="18" subjects_at_risk="178"/>
                <counts group_id="E5" events="18" subjects_affected="18" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="12" subjects_affected="10" subjects_at_risk="178"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Vitiligo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="19" subjects_affected="14" subjects_at_risk="178"/>
                <counts group_id="E5" events="19" subjects_affected="16" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="7" subjects_affected="5" subjects_at_risk="178"/>
                <counts group_id="E5" events="11" subjects_affected="11" subjects_at_risk="179"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E7" events="5" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="45"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="178"/>
                <counts group_id="E5" events="9" subjects_affected="9" subjects_at_risk="179"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="178"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="45"/>
              </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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT01704287
org study id: P08719
secondary id: MK-3475-002
secondary id: 2012-003030-17
secondary id: KEYNOTE-002
secondary id: P08719
nct id: NCT01704287
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study was conducted to compare survival using pembrolizumab (SCH 900475, MK-3475) or
      standard chemotherapy in participants with advanced melanoma (MEL) who had progressed after
      prior therapy.

      Initial Treatment Period:

      Participants were initially randomized to receive either low-dose (2 mg/kg) pembrolizumab,
      higher dose (10 mg/kg) pembrolizumab or Investigator-choice chemotherapy (ICC). The four
      standard chemotherapy choices were: carboplatin + paclitaxel, paclitaxel alone, dacarbazine,
      or temozolomide. The randomization to either pembrolizumab or ICC was conducted in an
      open-label fashion.

      The starting pembrolizumab dose was initially blinded to Investigators and participants until
      Amendment 03. With Amendment 03, all ongoing pembrolizumab participants were to be treated
      with open label, fixed dose pembrolizumab 200 mg, instead of a weight-based dosing of
      pembrolizumab.

      Switch-to-Pembrolizumab Treatment Period:

      Participants who were initially randomized to receive ICC and experienced progressive disease
      (PD) may have been eligible to switch to receiving pembrolizumab provided they met
      protocol-specified requirements for switching. Qualified participants were re-randomized to
      receive either pembrolizumab 2 mg/kg or pembrolizumab 10 mg/kg in a double-blind fashion.
      Participants who qualified to switch to pembrolizumab must have completed a washout period of
      ≥28 days from last dose of chemotherapy before receiving pembrolizumab. With Amendment 03,
      all switched-to-pembrolizumab participants were to be treated with open-label, fixed dose
      pembrolizumab 200 mg instead of a weight-based dosing of pembrolizumab.
Two interim and one final statistical analyses were planned for and conducted during this
      study:

        -  Interim Analysis 1 (futility analysis),

        -  Interim Analysis 2 (~18 months into study): database cutoff date 12-May-2014, and

        -  Final Analysis (~36 months into study): database cutoff date 16-Nov-2015. The End of
           Trial Analysis for the study was conducted at ~75 months into the study: database cutoff
           date 31-Jan-2019.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Progression-free Survival (PFS) - Initial Treatment Period
time frame: Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
description: PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Analysis of PFS was based on an integrated radiology and oncology (IRO) assessment and was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median PFS based on the product limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for PFS.
measure: Interim Overall Survival (OS) - Initial Treatment Period
time frame: Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
description: OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS.
measure: Final Overall Survival (OS) - Initial Treatment Period
time frame: Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
description: OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for OS.
measure: Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period
time frame: Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
description: OS was defined as the time from randomization to death due to any cause. Participants with an Allred Proportion Score (APS) ≥2 (membranous staining in ≥1% of cells for PD-L1) were considered to be PD-L1 Positive and participants with an APS of 0 or 1 were considered to be PD-L1 Negative. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data by PD-L1 tumor expression status is presented.
measure: Overall Response Rate (ORR) - Initial Treatment Period
time frame: Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
description: ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. Analysis of ORR was not planned or conducted for the switch-to-pembrolizumab treatment groups. The percentage of participants who experienced a CR or PR is presented. This was the final analysis for ORR.
measure: Best Overall Response (BOR) - Initial Treatment Period
time frame: Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
description: BOR was assessed by independent radiology review using RECIST 1.1 and was recorded from randomization until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. BOR for the Initial Treatment Period was based on IRO. BOR for participants during the Initial Treatment Period is presented.
measure: Best Overall Response (BOR) - Switch-to-Pembrolizumab Treatment Period
time frame: Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
description: The BOR was assessed using RECIST 1.1 and was recorded from the start of the second line of study drug (pembrolizumab) until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For the switch-to-pembrolizumab treatment groups, BOR was based on independent review committee (IRC) assessment. The BOR for switched-to pembrolizumab treatment groups is presented.
measure: Duration of Response (DOR) - Initial Treatment Period
time frame: Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
description: For participants who demonstrated a confirmed response (Complete Response [CR]: disappearance of all target lesions or Partial Response [PR]: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. DOR analysis was based on IRO assessment. Analysis of DOR was not planned or analyzed for the switch-to-pembrolizumab treatment groups. Median DOR for participants who demonstrated a confirmed response is presented.
measure: Number of Participants Who Experienced an Adverse Event (AE) - Overall Study
time frame: Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
description: An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE. Participants were included in the treatment group in which an AE was experienced. The number of participants who experienced at least one AE is presented.
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) - Overall Study
time frame: Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
description: An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented.
arm group label: Pembrolizumab 2 mg/kg
arm group type: Experimental
description: Participants were initially randomized to receive pembrolizumab 2 mg/kg intravenously (IV) once every 3 weeks (Q3W). With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
arm group label: Pembrolizumab 10 mg/kg
arm group type: Experimental
description: Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
arm group label: Investigator-Choice Chemotherapy (ICC)
arm group type: Active Comparator
description: Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)
arm group label: ICC→Pembrolizumab 2 mg/kg
arm group type: Experimental
description: Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
arm group label: ICC→Pembrolizumab 10 mg/kg
arm group type: Experimental
description: Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)
intervention type: Biological
intervention name: Pembrolizumab
description: IV infusion
arm group label: ICC→Pembrolizumab 10 mg/kg
arm group label: ICC→Pembrolizumab 2 mg/kg
arm group label: Pembrolizumab 10 mg/kg
arm group label: Pembrolizumab 2 mg/kg
other name: SCH 900475
other name: MK-3475
other name: KEYTRUDA®
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin per institutional standard
arm group label: ICC→Pembrolizumab 10 mg/kg
arm group label: ICC→Pembrolizumab 2 mg/kg
arm group label: Investigator-Choice Chemotherapy (ICC)
other name: PARAPLATIN®
intervention type: Drug
intervention name: Paclitaxel
description: Paclitaxel per institutional standard
arm group label: ICC→Pembrolizumab 10 mg/kg
arm group label: ICC→Pembrolizumab 2 mg/kg
arm group label: Investigator-Choice Chemotherapy (ICC)
other name: TAXOL®
intervention type: Drug
intervention name: Dacarbazine
description: Dacarbazine per institutional standard
arm group label: ICC→Pembrolizumab 10 mg/kg
arm group label: ICC→Pembrolizumab 2 mg/kg
arm group label: Investigator-Choice Chemotherapy (ICC)
other name: DTIC
intervention type: Drug
intervention name: Temozolomide
description: Temozolomide per institutional standard
arm group label: ICC→Pembrolizumab 10 mg/kg
arm group label: ICC→Pembrolizumab 2 mg/kg
arm group label: Investigator-Choice Chemotherapy (ICC)
other name: TEMODAR®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Argentina
country: Australia
country: Germany
country: Israel
country: Italy
country: Netherlands
country: Norway
country: Spain
country: Sweden
country: Switzerland
country: United States
url: http://merckoncologyclinicaltrials.com
description: Merck Oncology Clinical Trials Information
citation: Ribas A, Puzanov I, Dummer R, Schadendorf D, Hamid O, Robert C, Hodi FS, Schachter J, Pavlick AC, Lewis KD, Cranmer LD, Blank CU, O'Day SJ, Ascierto PA, Salama AK, Margolin KA, Loquai C, Eigentler TK, Gangadhar TC, Carlino MS, Agarwala SS, Moschos SJ, Sosman JA, Goldinger SM, Shapira-Frommer R, Gonzalez R, Kirkwood JM, Wolchok JD, Eggermont A, Li XN, Zhou W, Zernhelt AM, Lis J, Ebbinghaus S, Kang SP, Daud A. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):908-18. doi: 10.1016/S1470-2045(15)00083-2. Epub 2015 Jun 23.
PMID: 26115796
citation: Hamid O, Puzanov I, Dummer R, Schachter J, Daud A, Schadendorf D, Blank C, Cranmer LD, Robert C, Pavlick AC, Gonzalez R, Hodi FS, Ascierto PA, Salama AKS, Margolin KA, Gangadhar TC, Wei Z, Ebbinghaus S, Ibrahim N, Ribas A. Final analysis of a randomised trial comparing pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory advanced melanoma. Eur J Cancer. 2017 Nov;86:37-45. doi: 10.1016/j.ejca.2017.07.022.
PMID: 28961465
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Paclitaxel
mesh term: Carboplatin
mesh term: Pembrolizumab
mesh term: Temozolomide
mesh term: Dacarbazine
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 