<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/NCT01721772</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-066</org_study_id>
    <secondary_id>2012-003718-16</secondary_id>
    <nct_id>NCT01721772</nct_id>
  </id_info>
  <brief_title>Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma</brief_title>
  <acronym>CheckMate 066</acronym>
  <official_title>A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the clinical benefit, as measured by overall&#xD;
      survival, of nivolumab with that of. dacarbazine in patients with previously untreated,&#xD;
      unresectable, or metastatic melanoma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2013</start_date>
  <completion_date type="Actual">May 14, 2021</completion_date>
  <primary_completion_date type="Actual">June 24, 2014</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.</time_frame>
    <description>OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS) Rate</measure>
    <time_frame>From randomization to 6 months and or to 12 months</time_frame>
    <description>OS rate is calculated as the percentage of participants alive at the indicated timepoints</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>From date of randomization up to date of disease progression or death, up to approximately 84 months</time_frame>
    <description>Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS) Rate</measure>
    <time_frame>From randomization to the specified timepoints, up to 84 months</time_frame>
    <description>The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 months</time_frame>
    <description>ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level</measure>
    <time_frame>From date of randomization to date of disease progression or death, up to approximately 94 months</time_frame>
    <description>Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression &lt;5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Health-related Quality of Life (HRQoL) Scores</measure>
    <time_frame>At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months</time_frame>
    <description>HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">418</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Nivolumab, 3 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dacarbazine, 1000 mg/m^2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received dacarbazine, 1000 mg/m^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BMS-936558 (Nivolumab)</intervention_name>
    <arm_group_label>Nivolumab, 3 mg/kg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo matching BMS-936558 (Nivolumab)</intervention_name>
    <arm_group_label>Dacarbazine, 1000 mg/m^2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dacarbazine</intervention_name>
    <arm_group_label>Dacarbazine, 1000 mg/m^2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo matching Dacarbazine</intervention_name>
    <arm_group_label>Nivolumab, 3 mg/kg</arm_group_label>
  </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 and women ≥18 years of age&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1&#xD;
&#xD;
          -  Untreated and histologically confirmed unresectable Stage III or Stage IV melanoma, as&#xD;
             per the staging system of the American Joint Committee on Cancer&#xD;
&#xD;
          -  Measurable disease as per Response Evaluation Criteria in Solid Tumors 1.1&#xD;
&#xD;
          -  Tumor tissue from an unresectable or metastatic site of disease must be provided for&#xD;
             biomarker analyses&#xD;
&#xD;
          -  Known BRAF wild-type, as per regionally acceptable V600 mutational status testing.&#xD;
             BRAF mutant patients and those with indeterminate or unknown BRAF status are not&#xD;
             permitted to randomize&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active brain metastases or leptomeningeal metastases&#xD;
&#xD;
          -  Ocular melanoma&#xD;
&#xD;
          -  Any active, known, or suspected autoimmune disease&#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>Fundacion Cidea</name>
      <address>
        <city>Buenos Aires</city>
        <state>Distrito Federal</state>
        <zip>1121</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Medico Especialazado Alexander Fleming</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1426ANZ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Oncologico De Cordoba</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coffs Harbour Health Campus</name>
      <address>
        <city>Coffs Harbour</city>
        <state>New South Wales</state>
        <zip>2450</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0006</name>
      <address>
        <city>North Sydney</city>
        <state>New South Wales</state>
        <zip>2060</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenslopes Private Hospital</name>
      <address>
        <city>Greenslopes</city>
        <state>Queensland</state>
        <zip>4120</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabrini Hospital</name>
      <address>
        <city>Malvern</city>
        <state>Victoria</state>
        <zip>3144</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0039</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qe Ii Health Science Centre</name>
      <address>
        <city>Halfax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</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>Local Institution - 0040</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Viña Del Mar</city>
        <state>Valparaiso</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Santiago</city>
        <zip>7630370</zip>
        <country>Chile</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 - 0035</name>
      <address>
        <city>Helsinki</city>
        <zip>00290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Andre</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Grenoble - Hopital Albert Michallon</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chru De Lille - Hopital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital St Eloi</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0013</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>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Gera</city>
        <zip>07548</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Goettingen</city>
        <zip>37075</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>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Koeln</city>
        <zip>50937</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>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nuernberg</city>
        <zip>90419</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Recklinghausen</city>
        <zip>45659</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>Laiko Hospital</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metropolitan Hospital</name>
      <address>
        <city>Neo Faliro</city>
        <zip>18547</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</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>Tel Hashomer</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>Meldola (fc)</city>
        <zip>47014</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>Mexico</city>
        <state>Distrito Federal</state>
        <zip>03310</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tlalpan</city>
        <state>Distrito Federal</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Leon, Guanajato</city>
        <state>Guanajuato</state>
        <zip>37000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Morelia</city>
        <state>Michoacan</state>
        <zip>58240</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Oslo</city>
        <zip>0379</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Gdansk</city>
        <zip>80-219</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Lodz</city>
        <zip>93-513</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>San Sebastian</city>
        <state>Guipuzcoa</state>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0056</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28033</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sevilla</city>
        <zip>41009</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>Gothenberg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Umea</city>
        <zip>901 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Sweden</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_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</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <verification_date>June 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>November 20, 2015</results_first_submitted>
  <results_first_submitted_qc>January 27, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 25, 2016</results_first_posted>
  <disposition_first_submitted>July 3, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>July 3, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 28, 2015</disposition_first_posted>
  <last_update_submitted>June 17, 2022</last_update_submitted>
  <last_update_submitted_qc>June 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 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>Nivolumab</mesh_term>
    <mesh_term>Dacarbazine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>418 were randomized (210 to nivolumab, 208 to dacarbazine) and 411 received treatment (206 with nivolumab, 205 with dacarbazine).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
          <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
        </group>
        <group group_id="P2">
          <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
          <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Pre-Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="210"/>
                <participants group_id="P2" count="208"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="206"/>
                <participants group_id="P2" count="205"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participant no longer meets study criteria</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor/non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse event unrelated to study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </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="206"/>
                <participants group_id="P2" count="205"/>
              </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="206"/>
                <participants group_id="P2" count="205"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="119"/>
                <participants group_id="P2" count="168"/>
              </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="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse event unrelated to study drug</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Maximum clinical benefit</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request to discontinue study treatment</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not reported</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </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>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants randomized to receive treatment</population>
      <group_list>
        <group group_id="B1">
          <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
          <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
        </group>
        <group group_id="B2">
          <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
          <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</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="210"/>
            <count group_id="B2" value="208"/>
            <count group_id="B3" value="418"/>
          </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="61.6" spread="13.00"/>
                    <measurement group_id="B2" value="63.7" spread="12.60"/>
                    <measurement group_id="B3" value="62.7" spread="12.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Younger than 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="199"/>
                  </measurement_list>
                </category>
                <category>
                  <title>65 to younger than 75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="152"/>
                  </measurement_list>
                </category>
                <category>
                  <title>75 years and older</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="67"/>
                  </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="89"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="172"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="121"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="209"/>
                    <measurement group_id="B2" value="207"/>
                    <measurement group_id="B3" value="416"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaskan native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.</description>
        <time_frame>From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
            <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
          <group group_id="O2">
            <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
            <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.</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="210"/>
                <count group_id="O2" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA due to insufficient number of events</measurement>
                    <measurement group_id="O2" value="10.84" lower_limit="9.33" upper_limit="12.09"/>
                  </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>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Stratified Log Rank Test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.30</ci_lower_limit>
            <ci_upper_limit>0.60</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS)</title>
        <description>Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.</description>
        <time_frame>From date of randomization up to date of disease progression or death, up to approximately 84 months</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
            <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
          <group group_id="O2">
            <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
            <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS)</title>
          <description>Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.</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="210"/>
                <count group_id="O2" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.06" lower_limit="3.52" upper_limit="12.16"/>
                    <measurement group_id="O2" value="2.17" lower_limit="2.10" upper_limit="2.50"/>
                  </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>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Stratified Log Rank Test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.34</ci_lower_limit>
            <ci_upper_limit>0.56</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS) Rate</title>
        <description>The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.</description>
        <time_frame>From randomization to the specified timepoints, up to 84 months</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
            <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
          <group group_id="O2">
            <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
            <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) Rate</title>
          <description>The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.</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="210"/>
                <count group_id="O2" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.2" lower_limit="41.0" upper_limit="55.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="14.6" upper_limit="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3" lower_limit="36.3" upper_limit="50.2"/>
                    <measurement group_id="O2" value="7.4" lower_limit="3.9" upper_limit="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 18 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.5" lower_limit="33.5" upper_limit="47.4"/>
                    <measurement group_id="O2" value="5.2" lower_limit="2.2" upper_limit="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 24 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.8" lower_limit="29.0" upper_limit="42.6"/>
                    <measurement group_id="O2" value="5.2" lower_limit="2.2" upper_limit="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 36 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.8" lower_limit="26.1" upper_limit="39.6"/>
                    <measurement group_id="O2" value="3.9" lower_limit="1.3" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 48 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.7" lower_limit="23.2" upper_limit="36.5"/>
                    <measurement group_id="O2" value="3.9" lower_limit="1.3" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 60 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.4" lower_limit="22.0" upper_limit="35.2"/>
                    <measurement group_id="O2" value="3.9" lower_limit="1.3" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 72 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" lower_limit="21.4" upper_limit="34.5"/>
                    <measurement group_id="O2" value="3.9" lower_limit="1.3" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 84 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" lower_limit="19.5" upper_limit="32.7"/>
                    <measurement group_id="O2" value="3.9" lower_limit="1.3" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.</description>
        <time_frame>Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 months</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
            <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
          <group group_id="O2">
            <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
            <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.</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="210"/>
                <count group_id="O2" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.4" lower_limit="35.6" upper_limit="49.4"/>
                    <measurement group_id="O2" value="14.4" lower_limit="9.9" upper_limit="19.9"/>
                  </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>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.75</ci_lower_limit>
            <ci_upper_limit>7.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level</title>
        <description>Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression &lt;5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.</description>
        <time_frame>From date of randomization to date of disease progression or death, up to approximately 94 months</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
            <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
          <group group_id="O2">
            <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
            <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level</title>
          <description>Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression &lt;5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.</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="210"/>
                <count group_id="O2" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PD-L1 positive participants (cutoff=5%)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.36" lower_limit="31.47" upper_limit="NA">Upper limit not reached due to insufficient number of events</measurement>
                    <measurement group_id="O2" value="12.39" lower_limit="9.33" upper_limit="18.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD-L1 negative/indeterminate participants (cutoff=5%)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="136"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.97" lower_limit="16.36" upper_limit="39.79"/>
                    <measurement group_id="O2" value="10.84" lower_limit="8.38" upper_limit="12.25"/>
                  </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>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Unstratified Hazard Ratio</param_type>
            <param_value>0.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.24</ci_lower_limit>
            <ci_upper_limit>0.56</ci_upper_limit>
            <estimate_desc>PD-L1 positive group</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Unstratified Hazard Ratio</param_type>
            <param_value>0.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>0.80</ci_upper_limit>
            <estimate_desc>PD-L1 negative group</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS) Rate</title>
        <description>OS rate is calculated as the percentage of participants alive at the indicated timepoints</description>
        <time_frame>From randomization to 6 months and or to 12 months</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
            <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
          <group group_id="O2">
            <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
            <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) Rate</title>
          <description>OS rate is calculated as the percentage of participants alive at the indicated timepoints</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="210"/>
                <count group_id="O2" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.1" lower_limit="78.3" upper_limit="88.5"/>
                    <measurement group_id="O2" value="71.8" lower_limit="64.9" upper_limit="77.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.9" lower_limit="65.5" upper_limit="78.9"/>
                    <measurement group_id="O2" value="42.1" lower_limit="33.0" upper_limit="50.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Health-related Quality of Life (HRQoL) Scores</title>
        <description>HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.</description>
        <time_frame>At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months</time_frame>
        <population>All randomized participants with available measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
            <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
          <group group_id="O2">
            <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
            <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Health-related Quality of Life (HRQoL) Scores</title>
          <description>HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.</description>
          <population>All randomized participants with available measurements</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="210"/>
                <count group_id="O2" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.39" spread="19.46"/>
                    <measurement group_id="O2" value="2.32" spread="20.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.49" spread="18.91"/>
                    <measurement group_id="O2" value="3.81" spread="16.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.07" spread="16.58"/>
                    <measurement group_id="O2" value="3.15" spread="17.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.52" spread="20.25"/>
                    <measurement group_id="O2" value="-0.76" spread="21.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 31</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.53" spread="20.46"/>
                    <measurement group_id="O2" value="4.17" spread="17.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 37</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.26" spread="17.61"/>
                    <measurement group_id="O2" value="7.14" spread="18.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.69" spread="20.24"/>
                    <measurement group_id="O2" value="-1.04" spread="18.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.31" spread="18.95"/>
                    <measurement group_id="O2" value="3.33" spread="13.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 55</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.92" spread="18.26"/>
                    <measurement group_id="O2" value="12.50" spread="23.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.79" spread="18.72"/>
                    <measurement group_id="O2" value="13.89" spread="17.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 67</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.08" spread="21.92"/>
                    <measurement group_id="O2" value="8.33" spread="11.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 73</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.69" spread="17.10"/>
                    <measurement group_id="O2" value="12.50" spread="5.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 79</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.62" spread="18.84"/>
                    <measurement group_id="O2" value="8.33" spread="11.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.05" spread="19.43"/>
                    <measurement group_id="O2" value="12.50" spread="5.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.66" spread="20.92"/>
                    <measurement group_id="O2" value="16.67" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 97</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.27" spread="19.48"/>
                    <measurement group_id="O2" value="8.33" spread="11.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 103</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.20" spread="19.56"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 109</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.83" spread="20.75"/>
                    <measurement group_id="O2" value="8.33" spread="11.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 115</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.17" spread="21.15"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 121</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.47" spread="20.25"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 127</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.26" spread="19.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 133</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.16" spread="22.09"/>
                    <measurement group_id="O2" value="16.67" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 139</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.11" spread="21.86"/>
                    <measurement group_id="O2" value="16.67" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 145</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.69" spread="20.07"/>
                    <measurement group_id="O2" value="16.67" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 151</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.67" spread="20.34"/>
                    <measurement group_id="O2" value="16.67" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 157</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.53" spread="22.99"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 163</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.94" spread="20.83"/>
                    <measurement group_id="O2" value="16.67" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 169</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.33" spread="17.61"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 175</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.84" spread="23.66"/>
                    <measurement group_id="O2" value="50.00" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.42" spread="21.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 187</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.85" spread="22.06"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 193</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" spread="20.96"/>
                    <measurement group_id="O2" value="16.67" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 199</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.77" spread="21.13"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 205</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="24.07"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" spread="18.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 217</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.19" spread="23.32"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 223</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.26" spread="25.49"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 229</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.56" spread="23.77"/>
                    <measurement group_id="O2" value="16.67" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 235</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.39" spread="24.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 241</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.78" spread="25.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.36" spread="25.45"/>
                    <measurement group_id="O2" value="16.67" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 253</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.89" spread="26.89"/>
                    <measurement group_id="O2" value="16.67" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 259</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.05" spread="24.26"/>
                    <measurement group_id="O2" value="25.00" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 265</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.93" spread="21.55"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.25" spread="21.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 277</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.17" spread="21.12"/>
                    <measurement group_id="O2" value="25.00" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 283</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.56" spread="21.42"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 289</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.57" spread="20.86"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 295</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.47" spread="23.15"/>
                    <measurement group_id="O2" value="16.67" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 301</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.78" spread="23.92"/>
                    <measurement group_id="O2" value="16.67" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.52" spread="24.95"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 313</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.17" spread="24.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 319</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.33" spread="26.70"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 325</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.38" spread="25.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 331</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.71" spread="27.09"/>
                    <measurement group_id="O2" value="33.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 337</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.90" spread="26.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 343</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.67" spread="26.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 349</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.52" spread="26.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 355</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="10.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 361</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.83" spread="30.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 367</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.00" spread="36.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 373</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.00" spread="36.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 379</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 385</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 391</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 397</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 403</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.33" spread="NA">Insufficient number of participants to calculate standard deviation</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Overall Survival (OS) Extended</title>
        <description>OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. OS data for this endpoint was collected after the primary completion date up until study completion.</description>
        <time_frame>From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 94 months.</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
            <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
          <group group_id="O2">
            <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
            <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) Extended</title>
          <description>OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. OS data for this endpoint was collected after the primary completion date up until study completion.</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="210"/>
                <count group_id="O2" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.29" lower_limit="25.40" upper_limit="51.55"/>
                    <measurement group_id="O2" value="11.17" lower_limit="9.56" upper_limit="12.98"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.41</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Overall Survival (OS) Rate Extended</title>
        <description>OS rate is calculated as the percentage of participants alive at the indicated timepoints. Data for this endpoint was collected after the primary completion date up until study completion. The OS rate for the 6 month and 12 month timepoints reflect updated data that was collected after the primary completion date.</description>
        <time_frame>From randomization to the specified timepoints, up to 84 months</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
            <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
          <group group_id="O2">
            <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
            <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) Rate Extended</title>
          <description>OS rate is calculated as the percentage of participants alive at the indicated timepoints. Data for this endpoint was collected after the primary completion date up until study completion. The OS rate for the 6 month and 12 month timepoints reflect updated data that was collected after the primary completion date.</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="210"/>
                <count group_id="O2" value="208"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.2" lower_limit="41.0" upper_limit="55.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="14.6" upper_limit="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3" lower_limit="36.3" upper_limit="50.2"/>
                    <measurement group_id="O2" value="7.4" lower_limit="3.9" upper_limit="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.8" lower_limit="56.8" upper_limit="70.0"/>
                    <measurement group_id="O2" value="36.7" lower_limit="30.0" upper_limit="43.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.8" lower_limit="50.7" upper_limit="64.2"/>
                    <measurement group_id="O2" value="26.3" lower_limit="20.4" upper_limit="32.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.8" lower_limit="43.7" upper_limit="57.5"/>
                    <measurement group_id="O2" value="21.6" lower_limit="16.1" upper_limit="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.8" lower_limit="36.9" upper_limit="50.5"/>
                    <measurement group_id="O2" value="17.9" lower_limit="12.9" upper_limit="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.3" lower_limit="32.6" upper_limit="46.0"/>
                    <measurement group_id="O2" value="17.4" lower_limit="12.4" upper_limit="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.3" lower_limit="30.7" upper_limit="43.9"/>
                    <measurement group_id="O2" value="16.9" lower_limit="12.0" upper_limit="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>84 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2" lower_limit="29.5" upper_limit="42.8"/>
                    <measurement group_id="O2" value="16.9" lower_limit="12.0" upper_limit="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).</time_frame>
      <desc>All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants</desc>
      <group_list>
        <group group_id="E1">
          <title>Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine</title>
          <description>Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
        </group>
        <group group_id="E2">
          <title>Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab</title>
          <description>Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="126" subjects_at_risk="210"/>
                <counts group_id="E2" subjects_affected="165" subjects_at_risk="208"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="125" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="119" subjects_at_risk="205"/>
              </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="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness unilateral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hypopituitarism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Eyelid retraction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Retinal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Gastric mucosal lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pneumatosis intestinalis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Infusion site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchopulmonary aspergillosis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Coronavirus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Infected cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Infusion site infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Klebsiella infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Post procedural inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Radiation skin injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Spinal column injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood calcium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>General physical condition abnormal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pancreatic enzymes abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </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="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Bowen's disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Breast cancer recurrent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Gastrointestinal adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="69" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Melanoma recurrent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Metastases to lymph nodes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Metastatic malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Nodular melanoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Skin neoplasm bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Thyroid neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Facial paresis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Guillain-Barre syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Neurological decompensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Ectopic pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </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="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Renal injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Genital haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </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="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Sarcoid-like reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pelvic venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="191" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="187" subjects_at_risk="205"/>
              </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="26" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="75" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="58" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="104" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="77" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="205"/>
              </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="40" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="205"/>
              </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="46" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="205"/>
              </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="40" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Actinic keratosis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Photosensitivity reaction</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Vitiligo</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="205"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="205"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="205"/>
              </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>
    <limitations_and_caveats>An independent data monitoring committee (DMC) found that data from a DMC-requested database lock showed clear survival benefit with nivolumab and thus recommended unblinding the study and switching patients randomized to dacarbazine to nivolumab.</limitations_and_caveats>
    <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/NCT01721772
org study id: CA209-066
secondary id: 2012-003718-16
nct id: NCT01721772
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to compare the clinical benefit, as measured by overall
      survival, of nivolumab with that of. dacarbazine in patients with previously untreated,
      unresectable, or metastatic melanoma
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Overall Survival (OS)
time frame: From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.
description: OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.
measure: Overall Survival (OS) Rate
time frame: From randomization to 6 months and or to 12 months
description: OS rate is calculated as the percentage of participants alive at the indicated timepoints
measure: Progression-free Survival (PFS)
time frame: From date of randomization up to date of disease progression or death, up to approximately 84 months
description: Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were documented on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were documented on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were documented on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.
measure: Progression-free Survival (PFS) Rate
time frame: From randomization to the specified timepoints, up to 84 months
description: The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.
measure: Objective Response Rate (ORR)
time frame: Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 94 months
description: ORR is defined as the percentage of participants with a best overall response of Response Evaluation Criteria in Solid Tumors (RECIST) defined complete response (CR) or partial response (PR). RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.
measure: Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level
time frame: From date of randomization to date of disease progression or death, up to approximately 94 months
description: Overall Survival is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive. PD-L1 expression level is defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC (immunohistochemistry) assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% (PD-L1 positive) versus patients with tumor PD-L1 expression <5% (PD-L1 negative). Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.
measure: Change From Baseline in Health-related Quality of Life (HRQoL) Scores
time frame: At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months
description: HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.
arm group label: Nivolumab, 3 mg/kg
arm group type: Experimental
description: Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
arm group label: Dacarbazine, 1000 mg/m^2
arm group type: Active Comparator
description: Participants received dacarbazine, 1000 mg/m^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
intervention type: Biological
intervention name: BMS-936558 (Nivolumab)
arm group label: Nivolumab, 3 mg/kg
intervention type: Biological
intervention name: Placebo matching BMS-936558 (Nivolumab)
arm group label: Dacarbazine, 1000 mg/m^2
intervention type: Drug
intervention name: Dacarbazine
arm group label: Dacarbazine, 1000 mg/m^2
intervention type: Drug
intervention name: Placebo matching Dacarbazine
arm group label: Nivolumab, 3 mg/kg
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: Argentina
country: Australia
country: Canada
country: Chile
country: Denmark
country: Finland
country: France
country: Germany
country: Greece
country: Israel
country: Italy
country: Mexico
country: Norway
country: Poland
country: Spain
country: Sweden
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
description: BMS Clinical Trial Patient Recruiting
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Nivolumab
mesh term: Dacarbazine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: An independent data monitoring committee (DMC) found that data from a DMC-requested database lock showed clear survival benefit with nivolumab and thus recommended unblinding the study and switching patients randomized to dacarbazine to nivolumab.
point of contact: 