<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/NCT01721746</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-037</org_study_id>
    <secondary_id>2012-001828-35</secondary_id>
    <nct_id>NCT01721746</nct_id>
  </id_info>
  <brief_title>A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)</brief_title>
  <official_title>A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to estimate the response rate and compare overall survival of&#xD;
      patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or&#xD;
      Carboplatin and Paclitaxel&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2012</start_date>
  <completion_date type="Actual">December 29, 2020</completion_date>
  <primary_completion_date type="Actual">February 16, 2016</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)</time_frame>
    <description>Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 96 months</time_frame>
    <description>Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)</time_frame>
    <description>Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) by Baseline PD-L1 Expression</measure>
    <time_frame>From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)</time_frame>
    <description>Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) by PD-L1 Positive</measure>
    <time_frame>Up to 96 months</time_frame>
    <description>Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) by PD-L1 Negative</measure>
    <time_frame>Up to 96 months</time_frame>
    <description>Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Health-related Quality of Life (HRQoL)</measure>
    <time_frame>From Baseline (Day1) to second Follow-Up (Up to 96 months)</time_frame>
    <description>Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.&#xD;
Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.&#xD;
A 10 point difference on a 100 point scale between treatments was considered clinically significant.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">405</enrollment>
  <condition>Unresectable or Metastatic Melanoma</condition>
  <arm_group>
    <arm_group_label>BMS-936558 3 mg/kg (IV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMS-936558 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends&#xD;
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BMS-936558</intervention_name>
    <arm_group_label>BMS-936558 3 mg/kg (IV)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dacarbazine</intervention_name>
    <arm_group_label>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</arm_group_label>
    <other_name>DTIC-Dome</other_name>
    <other_name>DTIC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <arm_group_label>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</arm_group_label>
    <other_name>Paraplatin</other_name>
    <other_name>CBDCA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <arm_group_label>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</arm_group_label>
    <other_name>Onxol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding BMS clinical trial participation, please visit&#xD;
        www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Men &amp; women ≥ 18 years of age&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1&#xD;
&#xD;
          -  Histologically confirmed Stage III (unresectable)/Stage IV melanoma&#xD;
&#xD;
          -  Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per&#xD;
             Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria&#xD;
&#xD;
          -  Objective evidence of disease progression (clinical or radiological) during or after&#xD;
             at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment&#xD;
             regimens&#xD;
&#xD;
          -  Pre-treatment fresh core, excision or punch tumor biopsy&#xD;
&#xD;
          -  Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any treatment in a BMS-936558 (Nivolumab) trial&#xD;
&#xD;
          -  Subjects with condition requiring systemic treatment with either corticosteroids (&gt;&#xD;
             10mg daily prednisone/equivalent) or other immunosuppressive medications within 14&#xD;
             days of study drug administration&#xD;
&#xD;
          -  Active, known or suspected autoimmune disease&#xD;
&#xD;
          -  Unknown BRAF status&#xD;
&#xD;
          -  Active brain metastasis or leptomeningeal metastasis&#xD;
&#xD;
          -  Ocular melanoma&#xD;
&#xD;
          -  Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1&#xD;
             (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSD Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Angeles Clinic &amp; Research Institute</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of California - Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Francisco Oncology Associates</name>
      <address>
        <city>San Francciso</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Comprehensive Cancer Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School Of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Comprehensive Cancer Center</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Health, Inc</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center &amp; Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Michigan Health System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allina Health</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School Of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Clinical Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MSKCC Clinical Laboratory at Nassau</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Oncology And Hematology</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Network Office of Research and Innovation</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke'S Health System</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt-Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wien</city>
        <zip>A-1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Porto Alegre</city>
        <state>RIO Grande DO SUL</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20220-410</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01321-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 3E4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Mortimer B Davis - Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitetshospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Lille Cedex</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital La Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nantes Cedex 01</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nice</city>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wuerzburg</city>
        <state>Bayern</state>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Buxtehude</city>
        <zip>21614</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kiel</city>
        <zip>D-24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Luebeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tubingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bari</city>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Roma</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Barcelona</city>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28020</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Pamplona</city>
        <zip>31192</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Zuerich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <state>Tyne And Wear</state>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>Investigator Inquiry Form</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <results_first_submitted>February 1, 2017</results_first_submitted>
  <results_first_submitted_qc>February 1, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 22, 2017</results_first_posted>
  <last_update_submitted>March 23, 2022</last_update_submitted>
  <last_update_submitted_qc>March 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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>Nivolumab</mesh_term>
    <mesh_term>Dacarbazine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>405 participants randomized and 370 treated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Nivolumab</title>
          <description>Nivolumab 3 mg/kg IV over 60 minutes Q2W</description>
        </group>
        <group group_id="P2">
          <title>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</title>
          <description>Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Pre-Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="272"/>
                <participants group_id="P2" count="133"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="268"/>
                <participants group_id="P2" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participant request to discontinue Study treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor/Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant no longer met study criteria</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="268"/>
                <participants group_id="P2" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="268"/>
                <participants group_id="P2" count="102"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="192"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Drug Toxicity</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event unrelated to Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request to discontinue Study treatment</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Maximum Clinical Benefit</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor/Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant no longer met Study criteria</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reasons</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants</population>
      <group_list>
        <group group_id="B1">
          <title>Nivolumab</title>
          <description>Nivolumab 3 mg/kg IV over 60 minutes Q2W</description>
        </group>
        <group group_id="B2">
          <title>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</title>
          <description>Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W</description>
        </group>
        <group group_id="B3">
          <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="272"/>
            <count group_id="B2" value="133"/>
            <count group_id="B3" value="405"/>
          </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="58.7" spread="14.1"/>
                    <measurement group_id="B2" value="60.3" spread="12.4"/>
                    <measurement group_id="B3" value="59.2" 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="96"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="176"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="152"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="269"/>
                    <measurement group_id="B2" value="129"/>
                    <measurement group_id="B3" value="398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1</description>
        <time_frame>From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg IV over 60 minutes Q2W</description>
          </group>
          <group group_id="O2">
            <title>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</title>
            <description>Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1</description>
          <population>All randomized participants</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="272"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2" lower_limit="22.0" upper_limit="32.9"/>
                    <measurement group_id="O2" value="9.8" lower_limit="5.3" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.</description>
        <time_frame>Up to 96 months</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg IV over 60 minutes Q2W</description>
          </group>
          <group group_id="O2">
            <title>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</title>
            <description>Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.</description>
          <population>All randomized participants</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="272"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.74" lower_limit="12.88" upper_limit="19.88"/>
                    <measurement group_id="O2" value="14.39" lower_limit="11.66" upper_limit="18.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <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>1.08</ci_upper_limit>
            <estimate_desc>From stratified cox proportional hazard model with treatment group as a single covariate, stratified by BRAF status, prior anti-CTLA-4 benefit, and PD-L1 status (IVRS source)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS)</title>
        <description>Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.</description>
        <time_frame>From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg IV over 60 minutes Q2W</description>
          </group>
          <group group_id="O2">
            <title>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</title>
            <description>Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.</description>
          <population>All randomized participants</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="272"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.12" lower_limit="2.33" upper_limit="3.52"/>
                    <measurement group_id="O2" value="3.65" lower_limit="2.30" upper_limit="5.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
            <estimate_desc>Stratified Cox proportional hazard model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) by Baseline PD-L1 Expression</title>
        <description>Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.</description>
        <time_frame>From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)</time_frame>
        <population>All PD-L1 Evaluable Participants for ORR</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg IV over 60 minutes Q2W</description>
          </group>
          <group group_id="O2">
            <title>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</title>
            <description>Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) by Baseline PD-L1 Expression</title>
          <description>Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.</description>
          <population>All PD-L1 Evaluable Participants for ORR</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="267"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;5% PD-L1 expression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3" lower_limit="9.7" upper_limit="22.5"/>
                    <measurement group_id="O2" value="13.8" lower_limit="6.1" upper_limit="25.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=5% PD-L1 expression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.2" lower_limit="33.9" upper_limit="53.0"/>
                    <measurement group_id="O2" value="12.2" lower_limit="4.1" upper_limit="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For &lt;5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.13</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>3.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For &gt;=5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.92</ci_lower_limit>
            <ci_upper_limit>19.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS) by PD-L1 Positive</title>
        <description>Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.</description>
        <time_frame>Up to 96 months</time_frame>
        <population>All PD-L1 positive evaluable participants for OS</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg IV over 60 minutes Q2W</description>
          </group>
          <group group_id="O2">
            <title>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</title>
            <description>Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) by PD-L1 Positive</title>
          <description>Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.</description>
          <population>All PD-L1 positive evaluable participants for OS</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="135"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.44" lower_limit="20.57" upper_limit="46.69"/>
                    <measurement group_id="O2" value="16.72" lower_limit="11.83" upper_limit="31.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PD-L1 Positive</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <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>1.01</ci_upper_limit>
            <estimate_desc>From unstratified Cox proportional hazard model</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS) by PD-L1 Negative</title>
        <description>Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.</description>
        <time_frame>Up to 96 months</time_frame>
        <population>All PD-L1 negative evaluable participants for OS</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg IV over 60 minutes Q2W</description>
          </group>
          <group group_id="O2">
            <title>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</title>
            <description>Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) by PD-L1 Negative</title>
          <description>Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.</description>
          <population>All PD-L1 negative evaluable participants for OS</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="137"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.14" lower_limit="7.72" upper_limit="13.21"/>
                    <measurement group_id="O2" value="11.76" lower_limit="8.05" upper_limit="17.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PD-L1 Negative</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
            <estimate_desc>From unstratified Cox proportional hazard model</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Health-related Quality of Life (HRQoL)</title>
        <description>Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.&#xD;
Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.&#xD;
A 10 point difference on a 100 point scale between treatments was considered clinically significant.</description>
        <time_frame>From Baseline (Day1) to second Follow-Up (Up to 96 months)</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab 3 mg/kg IV over 60 minutes Q2W</description>
          </group>
          <group group_id="O2">
            <title>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</title>
            <description>Dacarbazine: 1000 mg/m^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m^2 IV Q3W</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Health-related Quality of Life (HRQoL)</title>
          <description>Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.&#xD;
Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.&#xD;
A 10 point difference on a 100 point scale between treatments was considered clinically significant.</description>
          <population>All randomized participants</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="272"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Functioning Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.97" spread="20.49"/>
                    <measurement group_id="O2" value="-12.73" spread="21.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.66" spread="16.05"/>
                    <measurement group_id="O2" value="-7.14" spread="16.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.94" spread="31.13"/>
                    <measurement group_id="O2" value="-15.91" spread="29.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.80" spread="25.56"/>
                    <measurement group_id="O2" value="-8.33" spread="21.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.09" spread="21.59"/>
                    <measurement group_id="O2" value="-15.48" spread="24.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.94" spread="19.15"/>
                    <measurement group_id="O2" value="-5.36" spread="25.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive Functioning Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.58" spread="16.79"/>
                    <measurement group_id="O2" value="-7.94" spread="17.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive Functioning Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.49" spread="15.43"/>
                    <measurement group_id="O2" value="-1.19" spread="13.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.66" spread="29.45"/>
                    <measurement group_id="O2" value="-18.25" spread="26.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.61" spread="29.52"/>
                    <measurement group_id="O2" value="-4.17" spread="24.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Health Status Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.23" spread="22.44"/>
                    <measurement group_id="O2" value="-10.71" spread="17.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Health Status Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.61" spread="18.53"/>
                    <measurement group_id="O2" value="-3.27" spread="12.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspnea Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.06" spread="27.96"/>
                    <measurement group_id="O2" value="16.67" spread="24.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspnea Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.91" spread="22.20"/>
                    <measurement group_id="O2" value="7.14" spread="24.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.46" spread="32.26"/>
                    <measurement group_id="O2" value="0.00" spread="30.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.84" spread="25.50"/>
                    <measurement group_id="O2" value="0.00" spread="30.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apatite loss Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.93" spread="28.79"/>
                    <measurement group_id="O2" value="13.64" spread="24.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Apatite loss Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.91" spread="30.49"/>
                    <measurement group_id="O2" value="2.38" spread="22.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.36" spread="28.93"/>
                    <measurement group_id="O2" value="0.00" spread="23.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.15" spread="22.48"/>
                    <measurement group_id="O2" value="-2.38" spread="29.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.43" spread="19.86"/>
                    <measurement group_id="O2" value="6.35" spread="22.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="20.88"/>
                    <measurement group_id="O2" value="1.19" spread="16.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Financial Difficulties Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.73" spread="25.87"/>
                    <measurement group_id="O2" value="4.76" spread="39.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Financial Difficulties Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.08" spread="22.56"/>
                    <measurement group_id="O2" value="-2.38" spread="28.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.95" spread="23.78"/>
                    <measurement group_id="O2" value="15.66" spread="28.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.84" spread="22.55"/>
                    <measurement group_id="O2" value="7.14" spread="21.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea and Vomiting Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.81" spread="17.19"/>
                    <measurement group_id="O2" value="10.61" spread="25.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea and Vomiting Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="15.39"/>
                    <measurement group_id="O2" value="2.98" spread="18.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Follow-Up 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.06" spread="31.17"/>
                    <measurement group_id="O2" value="6.82" spread="25.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Follow-Up 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.38" spread="24.84"/>
                    <measurement group_id="O2" value="-1.79" spread="14.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose to 100 days post last dose (Up to 96 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nivolumab</title>
          <description>Nivolumab 3 mg/kg IV over 60 minutes Q2W</description>
        </group>
        <group group_id="E2">
          <title>Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)</title>
          <description>Dacarbazine: 1000 mg/m^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m^2 IV over 180 minutes Q3W</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>23.1</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="206" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="88" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="191" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Febrile bone marrow aplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Splenic haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Splenic lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Intestinal fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Small intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pelvic mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hepatic haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hepatocellular injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Bronchitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Febrile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pneumonia pseudomonal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Vascular device infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Open fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Postoperative ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Radiation necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Vascular access site thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Ejection fraction abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>General physical condition abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Influenza B virus test positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Keratoacanthoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="86" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Melanoma recurrent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Metastases to adrenals</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Metastases to lung</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Metastases to pleura</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Metastatic malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Parathyroid tumour benign</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Skin neoplasm bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Tonsil cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Tumour associated fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Tumour fistulisation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Autoimmune neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Demyelination</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Facial paresis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Incoherent</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Monoplegia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Paraplegia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Post herpetic neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Status epilepticus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>VIth nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Burnout syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </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" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Skin haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Peripheral embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Superior vena cava syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>23.1</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="255" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="95" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="90" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="135" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="73" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="73" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Vitiligo</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="268"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="102"/>
              </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>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please Email:</phone>
      <email>Clinical.Trials@bms.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/NCT01721746
org study id: CA209-037
secondary id: 2012-001828-35
nct id: NCT01721746
lead sponsor: 
has dmc: Yes
The purpose of the study is to estimate the response rate and compare overall survival of
      patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or
      Carboplatin and Paclitaxel
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)
description: Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1
measure: Overall Survival (OS)
time frame: Up to 96 months
description: Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.
measure: Progression Free Survival (PFS)
time frame: From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)
description: Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.
measure: Objective Response Rate (ORR) by Baseline PD-L1 Expression
time frame: From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)
description: Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.
measure: Overall Survival (OS) by PD-L1 Positive
time frame: Up to 96 months
description: Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
measure: Overall Survival (OS) by PD-L1 Negative
time frame: Up to 96 months
description: Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
measure: Mean Change From Baseline in Health-related Quality of Life (HRQoL)
time frame: From Baseline (Day1) to second Follow-Up (Up to 96 months)
description: Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.
Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.
A 10 point difference on a 100 point scale between treatments was considered clinically significant.
arm group label: BMS-936558 3 mg/kg (IV)
arm group type: Experimental
description: BMS-936558 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
arm group label: Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
arm group type: Active Comparator
description: Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
intervention type: Biological
intervention name: BMS-936558
arm group label: BMS-936558 3 mg/kg (IV)
intervention type: Drug
intervention name: Dacarbazine
arm group label: Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
other name: DTIC-Dome
other name: DTIC
intervention type: Drug
intervention name: Carboplatin
arm group label: Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
other name: Paraplatin
other name: CBDCA
intervention type: Drug
intervention name: Paclitaxel
arm group label: Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
other name: Onxol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Austria
country: Belgium
country: Brazil
country: Canada
country: Denmark
country: France
country: Germany
country: Israel
country: Italy
country: Netherlands
country: Spain
country: Switzerland
country: United Kingdom
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: Investigator Inquiry Form
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Paclitaxel
mesh term: Carboplatin
mesh term: Nivolumab
mesh term: Dacarbazine
participant flow: 
baseline: 
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reported events: 
certain agreements: 
point of contact: 