<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/NCT02982954</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-920</org_study_id>
    <nct_id>NCT02982954</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer</brief_title>
  <acronym>CHECKMATE 920</acronym>
  <official_title>Phase 3b/4 Safety Trial of Nivolumab Combined With Ipilimumab in Subjects With Previously Untreated, Advanced or Metastatic RCC (CheckMate 920: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 920)</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>
      To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with&#xD;
      previously untreated advanced or metastatic Renal Cell Cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2017</start_date>
  <completion_date type="Actual">October 6, 2021</completion_date>
  <primary_completion_date type="Actual">May 11, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)</measure>
    <time_frame>Approximately 39 Months</time_frame>
    <description>Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)</measure>
    <time_frame>Approximately 39 Months</time_frame>
    <description>Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)</measure>
    <time_frame>From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks)</time_frame>
    <description>Time to onset is defined as the duration of time in weeks from the first dosing to the immune modulating adverse event onset date. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)</measure>
    <time_frame>From the IMAE onset date to the IMAE end date, up to approximately 194 weeks</time_frame>
    <description>Time to resolution is defined as the longest time from IMAE onset date to complete resolution or improvement to the grade at baseline experienced by the participant (the IMAE end date). Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)</measure>
    <time_frame>From first dose up to 100 days post last dose (up to approximately 29 months)</time_frame>
    <description>The number of participants who received immune modulating medication for participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)</measure>
    <time_frame>From first dose up to 100 days post last dose (up to approximately 29 months)</time_frame>
    <description>The number of participants who received Hormone Replacement Therapy for experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)</measure>
    <time_frame>From first dose up to 100 days post last dose (up to approximately 29 months)</time_frame>
    <description>The number of participants who received ≥ 40mg of prednisone for high grade (grades 3-5) IMAEs. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Progression Free Survival (PFS)</measure>
    <time_frame>From first dose to the date of the first documented progressive disease, up to approximately 12 months</time_frame>
    <description>PFS is defined as the time from first dose to the date of the first documented progressive disease (PD) as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause whichever occur first. Progressive disease is defined as progression of existing non-target lesions or 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. The appearance of one or more new lesions is also considered progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months)</time_frame>
    <description>ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (&lt; 10mm short axis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response Rate (TRR)</measure>
    <time_frame>From the date of first dose to first documented CR or PR, up to approximately 15 months</time_frame>
    <description>TTR is defined as the median percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (&lt; 10mm short axis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months</time_frame>
    <description>DOR is defined as the time between the date of first confirmed response to the date of the first documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause, whichever occurs first. DOR will be computed for participants who achieve partial response (PR) or complete response (CR) only. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (&lt; 10mm short axis).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">211</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>ccRCC KPS ≥ 70%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-ccRCC, KPS ≥ 70%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RCC with non-active Brain Mets, KPS ≥70%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>any RCC with KPS 50%-60%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Specified dose on specified day</description>
    <arm_group_label>Non-ccRCC, KPS ≥ 70%</arm_group_label>
    <arm_group_label>RCC with non-active Brain Mets, KPS ≥70%</arm_group_label>
    <arm_group_label>any RCC with KPS 50%-60%</arm_group_label>
    <arm_group_label>ccRCC KPS ≥ 70%</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Specified Dose on Specified Day</description>
    <arm_group_label>Non-ccRCC, KPS ≥ 70%</arm_group_label>
    <arm_group_label>RCC with non-active Brain Mets, KPS ≥70%</arm_group_label>
    <arm_group_label>any RCC with KPS 50%-60%</arm_group_label>
    <arm_group_label>ccRCC KPS ≥ 70%</arm_group_label>
    <other_name>Yervoy</other_name>
    <other_name>BMS-734016</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Type of Participant and Target Disease Characteristics&#xD;
&#xD;
          1. Advanced or metastatic RCC&#xD;
&#xD;
          2. Histologically confirmed, previously untreated (treatment-naive) RCC&#xD;
&#xD;
          3. No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy&#xD;
             for completely resectable RCC&#xD;
&#xD;
          4. Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as&#xD;
             measurable disease&#xD;
&#xD;
          5. Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of&#xD;
             50-60% for Cohort 4&#xD;
&#xD;
          6. Tumor tissue need be received by the central vendor (block or unstained slides). Note:&#xD;
             Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for&#xD;
             submission.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical Conditions&#xD;
&#xD;
               1. Subjects with any active autoimmune disease or a history of known autoimmune&#xD;
                  disease&#xD;
&#xD;
               2. Prior malignancy active within the previous 3 years except for locally curable&#xD;
                  cancers that have been apparently cured&#xD;
&#xD;
               3. Known HIV or AIDS-related illness&#xD;
&#xD;
               4. Any positive test for hepatitis B or hepatitis C virus indicating acute or&#xD;
                  chronic infection.&#xD;
&#xD;
          2. Prior/Concomitant Therapy&#xD;
&#xD;
               1. Prior systemic treatment in the metastatic setting with Vascular epithelial&#xD;
                  growth factor(VEGF) or VEGF receptor targeted therapy&#xD;
&#xD;
               2. Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2,&#xD;
                  anti-cluster of differentiation 137 (CD137), or anti-cytotoxic&#xD;
                  T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug&#xD;
                  specifically targeting T-cell co-stimulation or checkpoint pathways. This&#xD;
                  includes the utilization of these agents in the neo-adjuvant or adjuvant setting.&#xD;
&#xD;
               3. Anti-cancer therapy less than 28 days prior to the first dose of study drug or&#xD;
                  palliative, focal radiation therapy less than 14 days prior to the first dose of&#xD;
                  study drug.&#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>Northwest Alabama Cancer Center, Pc</name>
      <address>
        <city>Muscle Shoals</city>
        <state>Alabama</state>
        <zip>35661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alaska Urological Institute dba Alaska Clinical Research Center</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ironwood Cancer And Research Centers, Pc</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0028</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>eCare</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Shores Medical Group</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles Cancer Network</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology Oncology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Health Association</name>
      <address>
        <city>Redondo Beach</city>
        <state>California</state>
        <zip>90277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Group - Southern California</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Integrative Cancer Care</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Coast Med Oncology</name>
      <address>
        <city>Santa Maria</city>
        <state>California</state>
        <zip>93454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists S.</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Miami/Sylvester Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Cancer Center at Orlando Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University - Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Specialists</name>
      <address>
        <city>Niles</city>
        <state>Illinois</state>
        <zip>60714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0012</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center Of Kansas</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southdale Cancer Clinic</name>
      <address>
        <city>Burnsville</city>
        <state>Minnesota</state>
        <zip>55337</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0009</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Park Nicollet Clinic Cancer Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hattiesburg Clinic</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Oncology Associates, Pllc</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCA Midwest Division</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0023</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maimonides Medical Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Francis Cancer Treatment Center</name>
      <address>
        <city>Grand Island</city>
        <state>New York</state>
        <zip>68803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broome Oncology</name>
      <address>
        <city>Johnson City</city>
        <state>New York</state>
        <zip>13790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0052</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Medical Oncology Center</name>
      <address>
        <city>Goldsboro</city>
        <state>North Carolina</state>
        <zip>27534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0071</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Hematology Oncology Associates, Pa</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</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>Avera Cancer Institute</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC - SCRI - PPDS</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0002</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203-1624</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-6307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Fort Worth 12th Ave</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Midland Allison Cancer Center</name>
      <address>
        <city>Midland</city>
        <state>Texas</state>
        <zip>79701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22936</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0042</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours St Francis Hospital</name>
      <address>
        <city>Midlothian</city>
        <state>Virginia</state>
        <zip>23114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Institute</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23226</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>Medical Oncology Associates</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yakima Valley Memorial Hospital/North Star Lodge</name>
      <address>
        <city>Yakima</city>
        <state>Washington</state>
        <zip>98902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Clinical Science Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <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>http://www.BMSStudyConnect.com</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>http://www.fda.gov/safety/medwatch/safetyinformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <results_first_submitted>May 4, 2021</results_first_submitted>
  <results_first_submitted_qc>September 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 14, 2021</results_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 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>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT02982954/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT02982954/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1</title>
          <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2</title>
          <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
        </group>
        <group group_id="P3">
          <title>Cohort 3</title>
          <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
        </group>
        <group group_id="P4">
          <title>Cohort 4</title>
          <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="28"/>
                <participants group_id="P4" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="28"/>
                <participants group_id="P4" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reasons</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Premature site closure</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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1</title>
          <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2</title>
          <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
        </group>
        <group group_id="B3">
          <title>Cohort 3</title>
          <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
        </group>
        <group group_id="B4">
          <title>Cohort 4</title>
          <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
        </group>
        <group group_id="B5">
          <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="106"/>
            <count group_id="B2" value="52"/>
            <count group_id="B3" value="28"/>
            <count group_id="B4" value="25"/>
            <count group_id="B5" value="211"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.8" spread="9.43"/>
                    <measurement group_id="B2" value="60.1" spread="14.09"/>
                    <measurement group_id="B3" value="61.3" spread="11.06"/>
                    <measurement group_id="B4" value="65.2" spread="12.54"/>
                    <measurement group_id="B5" value="62.2" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)</title>
        <description>Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity</description>
        <time_frame>Approximately 39 Months</time_frame>
        <population>All Treated Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)</title>
          <description>Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity</description>
          <population>All Treated Participants</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="106"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pneumonitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea/Colitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatitis</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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nephritis and Renal Dysfunction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypersensitivity</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adrenal Insufficiency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypothyroidism and Thyroiditis</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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperthyroidism</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypophysitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)</title>
        <description>Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity</description>
        <time_frame>Approximately 39 Months</time_frame>
        <population>All Treated Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)</title>
          <description>Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity</description>
          <population>All Treated Participants</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="106"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pneumonitis</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea/Colitis</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatitis</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nephritis and Renal Dysfunction</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypersensitivity</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adrenal Insufficiency</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypothyroidism and Thyroiditis</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Mellitus</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperthyroidism</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypophysitis</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)</title>
        <description>Time to onset is defined as the duration of time in weeks from the first dosing to the immune modulating adverse event onset date. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
        <time_frame>From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks)</time_frame>
        <population>All Treated Participants Who Experienced at Least 1 IMAE Where Immune-modulating Medication was Initiated</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)</title>
          <description>Time to onset is defined as the duration of time in weeks from the first dosing to the immune modulating adverse event onset date. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
          <population>All Treated Participants Who Experienced at Least 1 IMAE Where Immune-modulating Medication was Initiated</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="106"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pneumonitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" lower_limit="12.7" upper_limit="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea/Colitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.79" lower_limit="1.7" upper_limit="115.7"/>
                    <measurement group_id="O2" value="10.43" lower_limit="4.4" upper_limit="20.1"/>
                    <measurement group_id="O3" value="11.0" lower_limit="10.1" upper_limit="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.43" lower_limit="2.0" upper_limit="82.1"/>
                    <measurement group_id="O2" value="9.4" lower_limit="9.4" upper_limit="9.4"/>
                    <measurement group_id="O3" value="11.6" lower_limit="11.6" upper_limit="11.6"/>
                    <measurement group_id="O4" value="10.1" lower_limit="10.1" upper_limit="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nephritis and Renal Dysfunction</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="9.43" lower_limit="1.4" upper_limit="17.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="1.1" upper_limit="80.4"/>
                    <measurement group_id="O2" value="6.14" lower_limit="2.3" upper_limit="13.7"/>
                    <measurement group_id="O3" value="8.3" lower_limit="8.3" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypersensitivity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Immune Mediated Arthritis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="38.9" lower_limit="38.9" upper_limit="38.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myositis/Rhabdomyolysis Event</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Adrenal Insufficiency</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.21" lower_limit="21.0" upper_limit="51.4"/>
                    <measurement group_id="O2" value="12.7" lower_limit="12.7" upper_limit="12.7"/>
                    <measurement group_id="O4" value="14.9" lower_limit="14.9" upper_limit="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypothyroidism and Thyroiditis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Diabetes Mellitus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="2.0" lower_limit="2.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperthyroidism</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Hypophysitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="18.7" lower_limit="18.7" upper_limit="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)</title>
        <description>Time to resolution is defined as the longest time from IMAE onset date to complete resolution or improvement to the grade at baseline experienced by the participant (the IMAE end date). Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
        <time_frame>From the IMAE onset date to the IMAE end date, up to approximately 194 weeks</time_frame>
        <population>All Treated Participants Who Experienced at Least 1 IMAE Where Immune-modulating Medication was Initiated</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)</title>
          <description>Time to resolution is defined as the longest time from IMAE onset date to complete resolution or improvement to the grade at baseline experienced by the participant (the IMAE end date). Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
          <population>All Treated Participants Who Experienced at Least 1 IMAE Where Immune-modulating Medication was Initiated</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="106"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pneumonitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="0.9" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea/Colitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.71" lower_limit="0.7" upper_limit="193.9"/>
                    <measurement group_id="O2" value="5.93" lower_limit="0.9" upper_limit="16.9"/>
                    <measurement group_id="O3" value="1.14" lower_limit="1.1" upper_limit="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="7.9" upper_limit="144.9">Median not calculated due to insufficient number of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="14.9" upper_limit="18.3">Median not calculated due to insufficient number of events.</measurement>
                    <measurement group_id="O3" value="3.00" lower_limit="3.0" upper_limit="3.0"/>
                    <measurement group_id="O4" value="2.1" lower_limit="2.1" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nephritis and Renal Dysfunction</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="7.79" lower_limit="1.1" upper_limit="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.86" lower_limit="5.3" upper_limit="181.6"/>
                    <measurement group_id="O2" value="8.00" lower_limit="3.1" upper_limit="69.9"/>
                    <measurement group_id="O3" value="5.3" lower_limit="5.3" upper_limit="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypersensitivity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Adrenal Insufficiency</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="0.4" upper_limit="170.0">Median not calculated due to insufficient number of events.</measurement>
                    <measurement group_id="O4" value="6.0" lower_limit="6.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Mellitus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1.1" lower_limit="1.1" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypophysitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="7.6" lower_limit="7.6" upper_limit="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immune Mediated Arthritis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="37.0" lower_limit="37.0" upper_limit="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)</title>
        <description>The number of participants who received immune modulating medication for participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
        <time_frame>From first dose up to 100 days post last dose (up to approximately 29 months)</time_frame>
        <population>All Treated Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)</title>
          <description>The number of participants who received immune modulating medication for participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
          <population>All Treated Participants</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="106"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pneumonitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea/Colitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nephritis and Renal Dysfunction</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypersensitivity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adrenal Insufficiency</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypothyroidism/Thyroiditis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Mellitus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperthyroidism</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypophysitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)</title>
        <description>The number of participants who received Hormone Replacement Therapy for experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
        <time_frame>From first dose up to 100 days post last dose (up to approximately 29 months)</time_frame>
        <population>Treated participants who experienced at least one Grade 3 to 5 Immune-Mediate Event from the category</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)</title>
          <description>The number of participants who received Hormone Replacement Therapy for experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
          <population>Treated participants who experienced at least one Grade 3 to 5 Immune-Mediate Event from the category</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="106"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pneumonitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea/Colitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nephritis and Renal Dysfunction</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypersensitivity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Adrenal Insufficiency</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypothyroidism and Thyroiditis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Diabetes Mellitus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperthyroidism</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Hypophysitis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)</title>
        <description>The number of participants who received ≥ 40mg of prednisone for high grade (grades 3-5) IMAEs. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
        <time_frame>From first dose up to 100 days post last dose (up to approximately 29 months)</time_frame>
        <population>All Treated Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)</title>
          <description>The number of participants who received ≥ 40mg of prednisone for high grade (grades 3-5) IMAEs. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death</description>
          <population>All Treated Participants</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="106"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Progression Free Survival (PFS)</title>
        <description>PFS is defined as the time from first dose to the date of the first documented progressive disease (PD) as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause whichever occur first. Progressive disease is defined as progression of existing non-target lesions or 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. The appearance of one or more new lesions is also considered progression.</description>
        <time_frame>From first dose to the date of the first documented progressive disease, up to approximately 12 months</time_frame>
        <population>All Treated Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
          </group>
        </group_list>
        <measure>
          <title>Median Progression Free Survival (PFS)</title>
          <description>PFS is defined as the time from first dose to the date of the first documented progressive disease (PD) as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause whichever occur first. Progressive disease is defined as progression of existing non-target lesions or 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. The appearance of one or more new lesions is also considered progression.</description>
          <population>All Treated Participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="3.0" upper_limit="8.4"/>
                    <measurement group_id="O2" value="3.7" lower_limit="2.7" upper_limit="4.6"/>
                    <measurement group_id="O3" value="8.5" lower_limit="2.9" upper_limit="12.0"/>
                    <measurement group_id="O4" value="3.6" lower_limit="2.5" upper_limit="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (&lt; 10mm short axis).</description>
        <time_frame>From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months)</time_frame>
        <population>All response evaluable participants: all treated participants who have baseline and at least one on-study evaluable tumor measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (&lt; 10mm short axis).</description>
          <population>All response evaluable participants: all treated participants who have baseline and at least one on-study evaluable tumor measurement.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="26"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.4" lower_limit="25.9" upper_limit="45.8"/>
                    <measurement group_id="O2" value="21.7" lower_limit="10.9" upper_limit="36.4"/>
                    <measurement group_id="O3" value="30.8" lower_limit="14.3" upper_limit="51.8"/>
                    <measurement group_id="O4" value="33.3" lower_limit="13.3" upper_limit="59.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Response Rate (TRR)</title>
        <description>TTR is defined as the median percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (&lt; 10mm short axis).</description>
        <time_frame>From the date of first dose to first documented CR or PR, up to approximately 15 months</time_frame>
        <population>All response evaluable participants: all treated participants who have baseline and at least one on-study evaluable tumor measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Response Rate (TRR)</title>
          <description>TTR is defined as the median percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (&lt; 10mm short axis).</description>
          <population>All response evaluable participants: all treated participants who have baseline and at least one on-study evaluable tumor measurement.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="26"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="2.5" upper_limit="14.6"/>
                    <measurement group_id="O2" value="2.8" lower_limit="2.1" upper_limit="4.5"/>
                    <measurement group_id="O3" value="2.8" lower_limit="2.4" upper_limit="3.0"/>
                    <measurement group_id="O4" value="4.5" lower_limit="2.5" upper_limit="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>DOR is defined as the time between the date of first confirmed response to the date of the first documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause, whichever occurs first. DOR will be computed for participants who achieve partial response (PR) or complete response (CR) only. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (&lt; 10mm short axis).</description>
        <time_frame>From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months</time_frame>
        <population>All response evaluable participants: all treated participants who have baseline and at least one on-study evaluable tumor measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O3">
            <title>Cohort 3</title>
            <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
          </group>
          <group group_id="O4">
            <title>Cohort 4</title>
            <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR)</title>
          <description>DOR is defined as the time between the date of first confirmed response to the date of the first documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause, whichever occurs first. DOR will be computed for participants who achieve partial response (PR) or complete response (CR) only. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (&lt; 10mm short axis).</description>
          <population>All response evaluable participants: all treated participants who have baseline and at least one on-study evaluable tumor measurement.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="26"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.01" lower_limit="7.10" upper_limit="NA">Upper limit not calculated due to insufficient number of events</measurement>
                    <measurement group_id="O2" value="37.68" lower_limit="10.87" upper_limit="NA">Upper limit not calculated due to insufficient number of events</measurement>
                    <measurement group_id="O3" value="16.51" lower_limit="3.88" upper_limit="47.87"/>
                    <measurement group_id="O4" value="19.48" lower_limit="6.28" upper_limit="20.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 29 months). Participants were assessed for All-cause mortality from their first dose to study completion (up to approximately 56 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1</title>
          <description>Nivolumab 6mg/kg IV plus, Ipilimumab 1mg/kg IV every 8 weeks alternating with Nivolumab 480 mg IV every 8 weeks, staggered every 4 weeks</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2</title>
          <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
        </group>
        <group group_id="E3">
          <title>Cohort 3</title>
          <description>Nivolumab 3mg/kg IV combined with Ipilimumab 1mg/kg IV every 3 weeks for 4 doses</description>
        </group>
        <group group_id="E4">
          <title>Cohort 4</title>
          <description>Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="25"/>
              </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="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Anaemia of chronic disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Splenic infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Ischaemic cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Incarcerated inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Intussusception</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Small intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </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="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Immune-mediated hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cryptosporidiosis infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Meningitis aseptic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </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="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>CSF white blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyperglycaemic hyperosmolar nonketotic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </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="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Immune-mediated arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Malignant pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Metastatic renal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Respiratory tract neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebellar infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypoxic-ischaemic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Myasthenia gravis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Vasogenic cerebral oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </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="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </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="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="103" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="25"/>
              </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="21" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </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="10" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </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="26" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </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="29" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </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="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </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="32" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="25"/>
              </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/NCT02982954
org study id: CA209-920
nct id: NCT02982954
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with
      previously untreated advanced or metastatic Renal Cell Cancer.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With High Grade (Grade 3-4) Immune Mediated Adverse Events (IMAEs)
time frame: Approximately 39 Months
description: Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
measure: Number of Participants With High Grade (Grade 5) Immune Mediated Adverse Events (IMAEs)
time frame: Approximately 39 Months
description: Number of participants with IMAEs in the following categories: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity
measure: Time to Onset of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
time frame: From first dose to the earliest IMAE (grade 3-5) event onset date (up to approximately 116 weeks)
description: Time to onset is defined as the duration of time in weeks from the first dosing to the immune modulating adverse event onset date. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
measure: Time to Resolution of Grade 3-5 Immune Mediated Adverse Events (IMAEs)
time frame: From the IMAE onset date to the IMAE end date, up to approximately 194 weeks
description: Time to resolution is defined as the longest time from IMAE onset date to complete resolution or improvement to the grade at baseline experienced by the participant (the IMAE end date). Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
measure: Number of Participants Who Received Immune Modulating Medication for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
time frame: From first dose up to 100 days post last dose (up to approximately 29 months)
description: The number of participants who received immune modulating medication for participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
measure: Number of Participants Who Received Hormone Replacement Therapy for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
time frame: From first dose up to 100 days post last dose (up to approximately 29 months)
description: The number of participants who received Hormone Replacement Therapy for experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
measure: Number of Participants Who Received ≥ 40mg of Prednisone for High Grade (Grades 3-5) Immune Mediated Adverse Events (IMAEs)
time frame: From first dose up to 100 days post last dose (up to approximately 29 months)
description: The number of participants who received ≥ 40mg of prednisone for high grade (grades 3-5) IMAEs. Participants experiencing all high grade (CTCAE v4 Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs) in the following categories will be included: Skin, Endocrine, Gastrointestinal, Hepatic, Renal, Pulmonary and Hypersensitivity. IMAEs are specific events (or groups of preferred terms describing specific events) considered as potential immune-mediated events by investigator, that meet the following definition: (1) those occurring within 100 days of the last dose (2) regardless of causality (3) with no clear alternate etiology based on investigator assessment, or with an immune-mediated component and (4) treated with immune-modulating medication. Grade 3= Severe reaction, Grade 4 = Life-threatening, Grade 5 = Death
measure: Median Progression Free Survival (PFS)
time frame: From first dose to the date of the first documented progressive disease, up to approximately 12 months
description: PFS is defined as the time from first dose to the date of the first documented progressive disease (PD) as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause whichever occur first. Progressive disease is defined as progression of existing non-target lesions or 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. The appearance of one or more new lesions is also considered progression.
measure: Objective Response Rate (ORR)
time frame: From first dose up to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (up to approximately 26 months)
description: ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
measure: Time to Response Rate (TRR)
time frame: From the date of first dose to first documented CR or PR, up to approximately 15 months
description: TTR is defined as the median percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of response evaluable participants. Best overall response is defined as the best response recorded from the start of the study treatment until the end of treatment. The participant's best overall response assignment will depend on the findings of both target and non-target disease and will also take into consideration the appearance of new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
measure: Duration of Response (DOR)
time frame: From first confirmed response to the date of the first documented tumor progression or death, up to approximately 48 months
description: DOR is defined as the time between the date of first confirmed response to the date of the first documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death due to any cause, whichever occurs first. DOR will be computed for participants who achieve partial response (PR) or complete response (CR) only. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) must be non-pathological in size (< 10mm short axis).
arm group label: ccRCC KPS ≥ 70%
arm group type: Experimental
description: Clear-Cell Renal Cell Carcinoma (ccRCC) with Karnofsky Performance Status (KPS) ≥ 70%
arm group label: Non-ccRCC, KPS ≥ 70%
arm group type: Experimental
description: Non Clear-Cell Renal Cell Carcinoma (nccRCC) with KPS ≥ 70%
arm group label: RCC with non-active Brain Mets, KPS ≥70%
arm group type: Experimental
description: Renal Cell Carcinoma (RCC) with non-active Brain Metastases, with KPS ≥70%
arm group label: any RCC with KPS 50%-60%
arm group type: Experimental
description: Renal Cell Carcinoma (RCC), regardless of any histology or existing non-active brain metastasis, with KPS 50%-60%
intervention type: Drug
intervention name: Nivolumab
description: Specified dose on specified day
arm group label: Non-ccRCC, KPS ≥ 70%
arm group label: RCC with non-active Brain Mets, KPS ≥70%
arm group label: any RCC with KPS 50%-60%
arm group label: ccRCC KPS ≥ 70%
other name: BMS-936558
other name: Opdivo
intervention type: Drug
intervention name: Ipilimumab
description: Specified Dose on Specified Day
arm group label: Non-ccRCC, KPS ≥ 70%
arm group label: RCC with non-active Brain Mets, KPS ≥70%
arm group label: any RCC with KPS 50%-60%
arm group label: ccRCC KPS ≥ 70%
other name: Yervoy
other name: BMS-734016
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: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: http://www.BMSStudyConnect.com
description: BMS Clinical Trial Patient Recruiting
url: http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Carcinoma, Renal Cell
mesh term: Nivolumab
mesh term: Ipilimumab
provided document: 
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