<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/NCT02996110</url>
  </required_header>
  <id_info>
    <org_study_id>CA018-005</org_study_id>
    <secondary_id>2016-003082-26</secondary_id>
    <nct_id>NCT02996110</nct_id>
  </id_info>
  <brief_title>A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma</brief_title>
  <acronym>FRACTION-RCC</acronym>
  <official_title>A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)</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 test the effectiveness and safety of various nivolumab&#xD;
      combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">November 23, 2021</completion_date>
  <primary_completion_date type="Actual">November 23, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR) Per Investigator</measure>
    <time_frame>From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)</time_frame>
    <description>ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR).&#xD;
BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first.&#xD;
For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy.&#xD;
CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to &lt;10 mm.&#xD;
PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.&#xD;
The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment.&#xD;
CR+PR, confidence interval based on Clopper and Pearson method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Median Duration of Response (DOR) Per Investigator</measure>
    <time_frame>From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks)</time_frame>
    <description>Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first.&#xD;
Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.&#xD;
Median computed using Kaplan -Meier method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression Free Survival Rate (PFSR) at 24 Weeks.</measure>
    <time_frame>24 weeks after first treatment dose.</time_frame>
    <description>The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.&#xD;
Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).&#xD;
Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs)</measure>
    <time_frame>From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)</time_frame>
    <description>Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) Leading to Discontinuation</measure>
    <time_frame>From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Died</measure>
    <time_frame>From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)</time_frame>
    <description>Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Thyroid Test Results - Track 1</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (approximately 108 weeks)</time_frame>
    <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Thyroid Test Results - Track 2</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (approximately 108 weeks)</time_frame>
    <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Hepatic Test Results - Track 1</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (approximately 108 weeks)</time_frame>
    <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Hepatic Test Results - Track 2</measure>
    <time_frame>From first dose to 30 days after last dose of study therapy (approximately 108 weeks)</time_frame>
    <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">182</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Nivolumab + Ipilimumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nivolumab + Ipilimumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nivolumab + Relatlimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab + Relatlimab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nivolumab + BMS-986205</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab + BMS-986205</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nivolumab + BMS-813160</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab + BMS-813160 (CCR2/5 dual antagonist)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Nivolumab + BMS-813160</arm_group_label>
    <arm_group_label>Nivolumab + BMS-986205</arm_group_label>
    <arm_group_label>Nivolumab + Ipilimumab</arm_group_label>
    <arm_group_label>Nivolumab + Relatlimab</arm_group_label>
    <other_name>Opdivo</other_name>
    <other_name>BMS-936558</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Nivolumab + Ipilimumab</arm_group_label>
    <other_name>BMS-734016</other_name>
    <other_name>Yervoy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Relatlimab</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Nivolumab + Relatlimab</arm_group_label>
    <other_name>BMS-986016</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986205</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Nivolumab + BMS-986205</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-813160</intervention_name>
    <description>Specified Dose on Specified Days</description>
    <arm_group_label>Nivolumab + BMS-813160</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced Renal Cell Carcinoma&#xD;
&#xD;
          -  Must have at least 1 lesion with measurable disease&#xD;
&#xD;
          -  Life expectancy of at least 3 months&#xD;
&#xD;
          -  Karnofsky Performance Status (KPS) must be =&gt;70%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients/subjects with suspected or known central nervous system metastases unless&#xD;
             adequately treated&#xD;
&#xD;
          -  Patients/subjects with autoimmune disease&#xD;
&#xD;
          -  Patients/subjects who need daily oxygen therapy&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria apply&#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>Local Institution - 0037</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612-9497</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0031</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0006</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0007</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0011</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0008</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0005</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0043</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0014</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0002</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hollings Cancer Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0025</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ut Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-8570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0024</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington - Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0032</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre Clayton</name>
      <address>
        <city>Bentleigh</city>
        <state>Victoria</state>
        <zip>3165</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0044</name>
      <address>
        <city>Linz</city>
        <state>Oberösterreich</state>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0038</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0029</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0035</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0034</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0030</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1R 2J6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0010</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0012</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.BMSStudyConnect.com</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <results_first_submitted>November 18, 2022</results_first_submitted>
  <results_first_submitted_qc>November 18, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 19, 2022</results_first_posted>
  <last_update_submitted>November 18, 2022</last_update_submitted>
  <last_update_submitted_qc>November 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
    <mesh_term>Relatlimab</mesh_term>
    <mesh_term>Linrodostat</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 11, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT02996110/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of the 178 participants that were treated, 60 were initially randomized to Track 1 and 118 were initially randomized to Track 2. The 152 participants that started treatment in Track 2 include the total number of participants that received treatment in each arm which incorporates the 35 participants from Track 1 or 2 that were re-randomized to receive a different treatment combination in Track 2.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
          <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="P2">
          <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
          <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="P3">
          <title>Arm 3: Nivolumab Plus BMS-986205</title>
          <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="P4">
          <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
          <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="P5">
          <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
          <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Pre-Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="56"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="17"/>
                <participants group_id="P5" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="55"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="17"/>
                <participants group_id="P5" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other Reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="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="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Track 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Re-Randomized to Track 2</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event Unrelated to Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Drug Toxicity</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Requested to Discontinue Study Treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Administrative Reason by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant no Longer Met Study Criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Track 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="21"/>
                <participants group_id="P5" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>No Pre-Randomization</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="17"/>
                <participants group_id="P5" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Re-Randomized From Track 1 Nivolumab + Relatlimab</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Re-Randomized From Track 1 Nivolumab + Ipilimumab</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Re-Randomized From Track 2 Nivolumab + Relatlimab</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Re-Randomized From Track 2 Nivolumab + BMS986205</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Previously Un-Treated But Re-Randomized</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Re-Randomized From Track 2 Nivolumab + Ipilimumab</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="20"/>
                <participants group_id="P5" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event Unrelated to Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Drug Toxicity</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Requested to Discontinue Study Treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Arms 1 and 2 take into account both Track 1 and Track 2 participants as well as those rerandomized to the respective arms in Track 2.</population>
      <group_list>
        <group group_id="B1">
          <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
          <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="B2">
          <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
          <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="B3">
          <title>Arm 3: Nivolumab Plus BMS-986205</title>
          <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="B4">
          <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
          <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="B5">
          <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
          <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="B6">
          <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="65"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="26"/>
            <count group_id="B4" value="17"/>
            <count group_id="B5" value="18"/>
            <count group_id="B6" value="182"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>The analysis population consists of all participants treated (including those re-randomized) in each Arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>The analysis population consists of all participants treated (including those re-randomized) in each Arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>The analysis population consists of all participants treated (including those re-randomized) in each Arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Track 2</title>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>The analysis population consists of all participants treated (including those re-randomized) in each Arm.</population>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian Indian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chinese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR) Per Investigator</title>
        <description>ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR).&#xD;
BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first.&#xD;
For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy.&#xD;
CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to &lt;10 mm.&#xD;
PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.&#xD;
The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment.&#xD;
CR+PR, confidence interval based on Clopper and Pearson method.</description>
        <time_frame>From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)</time_frame>
        <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
            <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
            <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: Nivolumab Plus BMS-986205</title>
            <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) Per Investigator</title>
          <description>ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR).&#xD;
BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first.&#xD;
For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy.&#xD;
CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to &lt;10 mm.&#xD;
PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.&#xD;
The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment.&#xD;
CR+PR, confidence interval based on Clopper and Pearson method.</description>
          <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
          <units>Percent 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="76"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Track 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="7.7" upper_limit="38.6"/>
                    <measurement group_id="O2" value="30" lower_limit="14.7" upper_limit="49.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Track 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" lower_limit="7.8" upper_limit="31.4"/>
                    <measurement group_id="O2" value="3.1" lower_limit="0.1" upper_limit="16.2"/>
                    <measurement group_id="O3" value="3.2" lower_limit="0.1" upper_limit="16.7"/>
                    <measurement group_id="O4" value="9.5" lower_limit="1.2" upper_limit="30.4"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Median Duration of Response (DOR) Per Investigator</title>
        <description>Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first.&#xD;
Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.&#xD;
Median computed using Kaplan -Meier method</description>
        <time_frame>From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks)</time_frame>
        <population>All treated participants with a best overall response of CR or PR. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
            <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
            <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: Nivolumab Plus BMS-986205</title>
            <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Duration of Response (DOR) Per Investigator</title>
          <description>Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first.&#xD;
Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.&#xD;
Median computed using Kaplan -Meier method</description>
          <population>All treated participants with a best overall response of CR or PR. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
          <units>Weeks</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Track 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="33.4" upper_limit="139.9">Insufficient number of participants with events. Five of the 6 participants received subsequent therapy prior to progression or death, thus their DOR was censored at the last tumor assessment.</measurement>
                    <measurement group_id="O2" value="32.57" lower_limit="0.1" upper_limit="52.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Track 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.00" lower_limit="0.1" upper_limit="117.6"/>
                    <measurement group_id="O2" value="99.4" lower_limit="99.4" upper_limit="99.4"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Insufficient number of participants with events</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival Rate (PFSR) at 24 Weeks.</title>
        <description>The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.&#xD;
Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).&#xD;
Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula</description>
        <time_frame>24 weeks after first treatment dose.</time_frame>
        <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
            <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
            <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: Nivolumab Plus BMS-986205</title>
            <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival Rate (PFSR) at 24 Weeks.</title>
          <description>The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.&#xD;
Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).&#xD;
Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula</description>
          <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
          <units>Proportion 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="76"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Track 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.491" lower_limit="0.294" upper_limit="0.661"/>
                    <measurement group_id="O2" value="0.429" lower_limit="0.246" upper_limit="0.600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Track 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.432" lower_limit="0.277" upper_limit="0.577"/>
                    <measurement group_id="O2" value="0.194" lower_limit="0.079" upper_limit="0.346"/>
                    <measurement group_id="O3" value="0.278" lower_limit="0.118" upper_limit="0.464"/>
                    <measurement group_id="O4" value="0.468" lower_limit="0.237" upper_limit="0.670"/>
                    <measurement group_id="O5" value="NA" lower_limit="NA" upper_limit="NA">Insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)</time_frame>
        <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
            <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
            <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: Nivolumab Plus BMS-986205</title>
            <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Track 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Track 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs)</title>
        <description>Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization</description>
        <time_frame>From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)</time_frame>
        <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
            <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
            <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: Nivolumab Plus BMS-986205</title>
            <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs)</title>
          <description>Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization</description>
          <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Track 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Track 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) Leading to Discontinuation</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)</time_frame>
        <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
            <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
            <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: Nivolumab Plus BMS-986205</title>
            <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) Leading to Discontinuation</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Track 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Track 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Died</title>
        <description>Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.</description>
        <time_frame>From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)</time_frame>
        <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
            <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
            <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: Nivolumab Plus BMS-986205</title>
            <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Died</title>
          <description>Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.</description>
          <population>All treated participants. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="62"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Track 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Track 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Thyroid Test Results - Track 1</title>
        <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (approximately 108 weeks)</time_frame>
        <population>All treated participants with at least one on-treatment TSH measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
            <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
            <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: Nivolumab Plus BMS-986205</title>
            <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Thyroid Test Results - Track 1</title>
          <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.</description>
          <population>All treated participants with at least one on-treatment TSH measurement</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TSH &gt; ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt; ULN WITH TSH &lt;= ULN AT BASELINE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt;ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE &lt;LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt;ULN WITH ALL OTHER FT3/FT4 TEST VALUES &gt;= LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt; ULN WITH FT3/FT4 TEST MISSING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt; LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH TSH &gt;= LLN AT BASELINE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE &gt; ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH ALL OTHER FT3/FT4 TEST VALUES &lt;= ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt; LLN WITH FT3/FT4 TEST MISSING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Thyroid Test Results - Track 2</title>
        <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (approximately 108 weeks)</time_frame>
        <population>All treated participants with at Least One On-Treatment TSH measurement. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
            <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
            <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: Nivolumab Plus BMS-986205</title>
            <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Thyroid Test Results - Track 2</title>
          <description>The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal</description>
          <population>All treated participants with at Least One On-Treatment TSH measurement. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TSH &gt; ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt; ULN WITH TSH &lt;= ULN AT BASELINE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt;ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE &lt;LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt;ULN WITH ALL OTHER FT3/FT4 TEST VALUES &gt;= LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt; ULN WITH FT3/FT4 TEST MISSING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt; LLN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH TSH &gt;= LLN AT BASELINE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE &gt; ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt;LLN WITH ALL OTHER FT3/FT4 TEST VALUES &lt;= ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt; LLN WITH FT3/FT4 TEST MISSING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Hepatic Test Results - Track 1</title>
        <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (approximately 108 weeks)</time_frame>
        <population>All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
            <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
            <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: Nivolumab Plus BMS-986205</title>
            <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Hepatic Test Results - Track 1</title>
          <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
          <population>All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT OR AST &gt; 3XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST&gt; 5XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST&gt; 10XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="00"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST &gt; 20XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TOTAL BILIRUBIN &gt; 2XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT/AST ELEV&gt;3XULN;TOTAL BILIRUBIN&gt;2XULN IN 1 DAY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT/AST ELEV&gt;3XULN;TOTAL BILIRUBIN&gt;2XULN IN 30 DAYS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Hepatic Test Results - Track 2</title>
        <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
        <time_frame>From first dose to 30 days after last dose of study therapy (approximately 108 weeks)</time_frame>
        <population>All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
            <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
            <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: Nivolumab Plus BMS-986205</title>
            <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O4">
            <title>Arm 4: Nivolumab Plus BMS-813160 150 mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
          <group group_id="O5">
            <title>Arm 5: Nivolumab Plus BMS-813160 300mg</title>
            <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Hepatic Test Results - Track 2</title>
          <description>The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal</description>
          <population>All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement. Some participants were re-randomized to receive multiple treatment options during the course of the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT OR AST &gt; 3XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST&gt; 5XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST&gt; 10XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT OR AST &gt; 20XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TOTAL BILIRUBIN &gt; 2XULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT/AST ELEV&gt;3XULN;TOTAL BILIRUBIN&gt;2XULN IN 1 DAY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT/AST ELEV&gt;3XULN;TOTAL BILIRUBIN&gt;2XULN IN 30 DAYS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 250 weeks). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks).</time_frame>
      <desc>The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Track 1: Nivolumab Plus Ipilimumab (BMS-734016)</title>
          <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="E2">
          <title>Track 1: Nivolumab Plus Relatlimab (BMS-986016)</title>
          <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="E3">
          <title>Track 2: Nivolumab Plus Ipilimumab (BMS-734016)</title>
          <description>Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="E4">
          <title>Track 2: Nivolumab Plus Relatlimab (BMS-986016)</title>
          <description>Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="E5">
          <title>Track 2: Nivolumab Plus BMS-986205</title>
          <description>Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="E6">
          <title>Track 2: Nivolumab Plus BMS-813160 150 mg</title>
          <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
        <group group_id="E7">
          <title>Track 2: Nivolumab Plus BMS-813160 300 mg</title>
          <description>Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>25.0</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="12" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="31"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="13" subjects_at_risk="32"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="13" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="16" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="15" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Immune-mediated adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lip swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Mouth haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Small intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pneumonia influenzal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sialoadenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Post procedural haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Autoimmune myositis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Polymyalgia rheumatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Metastases to lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Metastatic renal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Immune-mediated neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pyramidal tract syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Bladder perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Immune-mediated nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oliguria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Renal haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>25.0</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="28" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="42" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="29" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="17" subjects_at_risk="22"/>
              </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="8" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Epigastric discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </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="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Taste disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </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="11" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please Email</phone>
      <email>Clinical.Trials@bms.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996110
org study id: CA018-005
secondary id: 2016-003082-26
nct id: NCT02996110
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to test the effectiveness and safety of various nivolumab
      combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR) Per Investigator
time frame: From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks)
description: ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR).
BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first.
For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy.
CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm.
PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment.
CR+PR, confidence interval based on Clopper and Pearson method.
measure: Median Duration of Response (DOR) Per Investigator
time frame: From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks)
description: Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first.
Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Median computed using Kaplan -Meier method
measure: Progression Free Survival Rate (PFSR) at 24 Weeks.
time frame: 24 weeks after first treatment dose.
description: The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.
Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula
measure: Number of Participants With Adverse Events (AEs)
time frame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
measure: Number of Participants With Serious Adverse Events (SAEs)
time frame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
description: Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization
measure: Number of Participants With Adverse Events (AEs) Leading to Discontinuation
time frame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
measure: Number of Participants Who Died
time frame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks)
description: Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.
measure: Number of Participants With Abnormal Thyroid Test Results - Track 1
time frame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
description: The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
measure: Number of Participants With Abnormal Thyroid Test Results - Track 2
time frame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
description: The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
measure: Number of Participants With Abnormal Hepatic Test Results - Track 1
time frame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
description: The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
measure: Number of Participants With Abnormal Hepatic Test Results - Track 2
time frame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks)
description: The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
arm group label: Nivolumab + Ipilimumab
arm group type: Active Comparator
description: Nivolumab + Ipilimumab
arm group label: Nivolumab + Relatlimab
arm group type: Experimental
description: Nivolumab + Relatlimab
arm group label: Nivolumab + BMS-986205
arm group type: Experimental
description: Nivolumab + BMS-986205
arm group label: Nivolumab + BMS-813160
arm group type: Experimental
description: Nivolumab + BMS-813160 (CCR2/5 dual antagonist)
intervention type: Biological
intervention name: Nivolumab
description: Specified Dose on Specified Days
arm group label: Nivolumab + BMS-813160
arm group label: Nivolumab + BMS-986205
arm group label: Nivolumab + Ipilimumab
arm group label: Nivolumab + Relatlimab
other name: Opdivo
other name: BMS-936558
intervention type: Biological
intervention name: Ipilimumab
description: Specified Dose on Specified Days
arm group label: Nivolumab + Ipilimumab
other name: BMS-734016
other name: Yervoy
intervention type: Biological
intervention name: Relatlimab
description: Specified Dose on Specified Days
arm group label: Nivolumab + Relatlimab
other name: BMS-986016
intervention type: Drug
intervention name: BMS-986205
description: Specified Dose on Specified Days
arm group label: Nivolumab + BMS-986205
intervention type: Drug
intervention name: BMS-813160
description: Specified Dose on Specified Days
arm group label: Nivolumab + BMS-813160
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: Australia
country: Austria
country: Canada
country: Israel
country: Italy
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: Carcinoma, Renal Cell
mesh term: Nivolumab
mesh term: Ipilimumab
mesh term: Relatlimab
mesh term: Linrodostat
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 