<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT02231749</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-214</org_study_id>
    <secondary_id>2014-001750-42</secondary_id>
    <nct_id>NCT02231749</nct_id>
  </id_info>
  <brief_title>Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)</brief_title>
  <official_title>A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the objective response rate, progression free&#xD;
      survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib&#xD;
      monotherapy in patients with previously untreated Renal Cell Cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 16, 2014</start_date>
  <completion_date type="Anticipated">August 7, 2027</completion_date>
  <primary_completion_date type="Actual">June 26, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1</measure>
    <time_frame>From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)</time_frame>
    <description>ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</measure>
    <time_frame>From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)</time_frame>
    <description>OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact (&quot;last known alive date&quot;) for subjects who were alive.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</measure>
    <time_frame>From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)</time_frame>
    <description>PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1</measure>
    <time_frame>From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)</time_frame>
    <description>ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</measure>
    <time_frame>From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)</time_frame>
    <description>Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact (&quot;last known alive date&quot;). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after subject's off-treatment date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</measure>
    <time_frame>From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)</time_frame>
    <description>PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1390</enrollment>
  <condition>Advanced Renal Cell Carcinoma</condition>
  <condition>Metastatic Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Sunitinib 50 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends&#xD;
After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <arm_group_label>Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg</arm_group_label>
    <arm_group_label>Arm B: Sunitinib 50 mg</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <arm_group_label>Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg</arm_group_label>
    <arm_group_label>Arm B: Sunitinib 50 mg</arm_group_label>
    <other_name>Yervoy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sunitinib</intervention_name>
    <arm_group_label>Arm B: Sunitinib 50 mg</arm_group_label>
    <other_name>Sutent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding BMS clinical trial participation, please visit&#xD;
        www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component&#xD;
&#xD;
          -  Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC&#xD;
             Stage IV) RCC&#xD;
&#xD;
          -  No prior systemic therapy for RCC with the following exception:&#xD;
&#xD;
               1. One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such&#xD;
                  therapy did not include an agent that targets vascular endothelial growth factor&#xD;
                  (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the&#xD;
                  last dose of adjuvant or neoadjuvant therapy&#xD;
&#xD;
                    -  Karnofsky Performance Status (KPS) of at least 70%&#xD;
&#xD;
                    -  Measurable disease as per Response Evaluation Criteria in Solid Tumors&#xD;
                       (RECIST) 1.1&#xD;
&#xD;
                    -  Tumor tissue [formalin-fixed paraffin-embedded (FFPE) archival or recent&#xD;
                       acquisition] must be received by the central vendor (block or unstained&#xD;
                       slides) in order to randomize a subject to study treatment. (Note: Fine&#xD;
                       Needle Aspiration [FNA] and bone metastases samples are not acceptable for&#xD;
                       submission)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history of or current central nervous system (CNS) metastases. Baseline imaging of&#xD;
             the brain is required within 28 days prior to randomization&#xD;
&#xD;
          -  Prior systemic treatment with VEGF or VEGF receptor targeted therapy (including, but&#xD;
             not limited to, Sunitinib, Pazopanib, Axitinib, Tivozanib, and Bevacizumab)&#xD;
&#xD;
          -  Prior treatment with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD-L2,&#xD;
             anti-CD137, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody, or any other&#xD;
             antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways&#xD;
&#xD;
          -  Any active or recent history of a known or suspected autoimmune disease or recent&#xD;
             history of a syndrome that required systemic corticosteroids (&gt;10 mg daily Prednisone&#xD;
             equivalent) or immunosuppressive medications except for syndromes which would not be&#xD;
             expected to recur in the absence of an external trigger. Subjects with vitiligo or&#xD;
             type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only&#xD;
             requiring hormone replacement are permitted to enroll&#xD;
&#xD;
          -  Any condition requiring systemic treatment with corticosteroids (&gt;10 mg daily&#xD;
             Prednisone equivalents) or other immunosuppressive medications within 14 days prior to&#xD;
             first dose of study drug. Inhaled steroids and adrenal replacement steroid doses &gt;10&#xD;
             mg daily Prednisone equivalents are permitted in the absence of active autoimmune&#xD;
             disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
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    <facility>
      <name>Local Institution - 0006</name>
      <address>
        <city>Duarte</city>
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      <name>Local Institution - 0076</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0075</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0140</name>
      <address>
        <city>Elizabeth Vale</city>
        <state>South Australia</state>
        <zip>5112</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0072</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0071</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0104</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0074</name>
      <address>
        <city>Murdoch</city>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0108</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0107</name>
      <address>
        <city>Wels</city>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0109</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0020</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0019</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0152</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30130-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0150</name>
      <address>
        <city>Porto Alegre</city>
        <state>RIO Grande DO SUL</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0151</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>91610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0153</name>
      <address>
        <city>Sao Paulo</city>
        <state>São Paulo</state>
        <zip>01321-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0157</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20793-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0155</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01406-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0156</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01509-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0149</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0133</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0182</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 5L3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0128</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0131</name>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <zip>E1C 8X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0172</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0148</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0132</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0101</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <zip>8420383</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0102</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0144</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0103</name>
      <address>
        <city>Vina del Mar</city>
        <zip>254 0364</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0080</name>
      <address>
        <city>Bogota</city>
        <zip>0</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0162</name>
      <address>
        <city>Medellin</city>
        <zip>0</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0081</name>
      <address>
        <city>Medellin</city>
        <zip>MEDELLIN</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0050</name>
      <address>
        <city>Liberec</city>
        <state>Liberecký Kraj</state>
        <zip>460 63</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0053</name>
      <address>
        <city>Brno</city>
        <zip>656 53</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0051</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0052</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0136</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0158</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0137</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0027</name>
      <address>
        <city>Helsinki</city>
        <zip>00290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0028</name>
      <address>
        <city>Tampere</city>
        <zip>33521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0170</name>
      <address>
        <city>Besancon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0062</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0169</name>
      <address>
        <city>La Roche-Sur-Yon Cedex 9</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0060</name>
      <address>
        <city>Marseille Cedex 9</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0063</name>
      <address>
        <city>Saint Herblain</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0065</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0059</name>
      <address>
        <city>Toulouse Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0058</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0061</name>
      <address>
        <city>Paris</city>
        <state>Île-de-France</state>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0125</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0126</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0141</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0147</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0142</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0123</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0127</name>
      <address>
        <city>Homburg</city>
        <zip>66424</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0129</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0143</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0124</name>
      <address>
        <city>Muenchen</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0146</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0130</name>
      <address>
        <city>Ulm</city>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0184</name>
      <address>
        <city>Gyula</city>
        <state>Békés</state>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0083</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0082</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0084</name>
      <address>
        <city>Pecs</city>
        <zip>7624</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0015</name>
      <address>
        <city>Wilton</city>
        <state>Cork</state>
        <zip>0</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0017</name>
      <address>
        <city>Dublin 7</city>
        <state>Dublin</state>
        <zip>0</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0018</name>
      <address>
        <city>Dublin 7</city>
        <state>Dublin</state>
        <zip>0</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0016</name>
      <address>
        <city>Dublin</city>
        <zip>24</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0120</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0117</name>
      <address>
        <city>Kfar Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0121</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0118</name>
      <address>
        <city>Ramat-gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0119</name>
      <address>
        <city>Zerifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0022</name>
      <address>
        <city>Arezzo</city>
        <zip>52100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0024</name>
      <address>
        <city>Meldola (fc)</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0023</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0064</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0079</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0025</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0026</name>
      <address>
        <city>Roma</city>
        <zip>00149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0192</name>
      <address>
        <city>Akita-shi</city>
        <state>Akita</state>
        <zip>010-8542</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0209</name>
      <address>
        <city>Hirosaki-shi</city>
        <state>Aomori</state>
        <zip>036-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0187</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0196</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>8128582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0188</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokai-do</state>
        <zip>060-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>0608648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0206</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>6500017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0205</name>
      <address>
        <city>Tsukuba-shi</city>
        <state>Ibaraki</state>
        <zip>3058576</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0200</name>
      <address>
        <city>Morioka-shi</city>
        <state>Iwate</state>
        <zip>0208505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0186</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <zip>2360004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0189</name>
      <address>
        <city>Kumamoto-shi</city>
        <state>Kumamoto</state>
        <zip>8608556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0191</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>6028566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0199</name>
      <address>
        <city>Niigata-shi</city>
        <state>Niigata</state>
        <zip>9518520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0204</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>7008558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0190</name>
      <address>
        <city>Osaka-sayama</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0201</name>
      <address>
        <city>Suita-shi</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0208</name>
      <address>
        <city>Hamamatsu-shi</city>
        <state>Shizuoka</state>
        <zip>4313192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0194</name>
      <address>
        <city>Tokushima-shi</city>
        <state>Tokushima</state>
        <zip>770-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0202</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0197</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>1138431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0195</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>1138655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0207</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <zip>1358550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0185</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Tokyo</state>
        <zip>1608582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0193</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>1628666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0198</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0203</name>
      <address>
        <city>Yamagata</city>
        <zip>9909585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0178</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0177</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0176</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0168</name>
      <address>
        <city>Mexico D.f.</city>
        <state>Distrito Federal</state>
        <zip>14050</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0171</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0175</name>
      <address>
        <city>Queretaro</city>
        <state>Querétaro</state>
        <zip>76090</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0167</name>
      <address>
        <city>Oaxaca</city>
        <zip>68000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0029</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0040</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0030</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0093</name>
      <address>
        <city>Krakow</city>
        <zip>31-115</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0112</name>
      <address>
        <city>Poznan</city>
        <zip>60-569</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0106</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-556</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0089</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0088</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0086</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0085</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0087</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0111</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0090</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0134</name>
      <address>
        <city>Solna</city>
        <zip>171 64</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0179</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0180</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0181</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0115</name>
      <address>
        <city>Altindağ</city>
        <state>Ankara</state>
        <zip>06230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0114</name>
      <address>
        <city>Antalya</city>
        <zip>07070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0122</name>
      <address>
        <city>Istanbul</city>
        <zip>34890</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0010</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0009</name>
      <address>
        <city>Glasgow</city>
        <state>Lanarkshire</state>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0077</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0021</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0011</name>
      <address>
        <city>Northwood</city>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0012</name>
      <address>
        <city>Swansea</city>
        <zip>SA2 8QA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <results_first_submitted>June 21, 2018</results_first_submitted>
  <results_first_submitted_qc>October 12, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 16, 2018</results_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</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</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
    <mesh_term>Sunitinib</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>November 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT02231749/Prot_001.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>September 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT02231749/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total 1390 patients were enrolled in the study. Of these, 1096 were randomized. Of those randomized, 1082 received treatment (547 with Nivo+Ipi and 535 with Sunitinib). 240 patients who were not randomized because they no longer met study criteria, 24 withdrew consent, 4 for Adverse Events, 4 for Death, 4 for Poor Compliance, and 18 other.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Nivolumab + Ipilimumab</title>
          <description>Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
        </group>
        <group group_id="P2">
          <title>Sunitinib</title>
          <description>Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="550"/>
                <participants group_id="P2" count="546"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="547"/>
                <participants group_id="P2" count="535"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="422"/>
                <participants group_id="P2" count="449"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="229"/>
                <participants group_id="P2" count="297"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Drug Toxicity</title>
              <participants_list>
                <participants group_id="P1" count="134"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>AE unrelated to Study drug</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant's request to discontinue</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Maximum Clinical Benefit</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor/Non-Compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer meets Study Criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All Randomized Participants</population>
      <group_list>
        <group group_id="B1">
          <title>Nivolumab + Ipilimumab</title>
          <description>Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
        </group>
        <group group_id="B2">
          <title>Sunitinib</title>
          <description>Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="550"/>
            <count group_id="B2" value="546"/>
            <count group_id="B3" value="1096"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>All Randomized</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.1" spread="9.76"/>
                    <measurement group_id="B2" value="60.7" spread="10.10"/>
                    <measurement group_id="B3" value="60.9" spread="9.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>All Randomized Participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="137"/>
                    <measurement group_id="B2" value="151"/>
                    <measurement group_id="B3" value="288"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="413"/>
                    <measurement group_id="B2" value="395"/>
                    <measurement group_id="B3" value="808"/>
                  </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="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="264"/>
                    <measurement group_id="B2" value="253"/>
                    <measurement group_id="B3" value="517"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="274"/>
                    <measurement group_id="B2" value="276"/>
                    <measurement group_id="B3" value="550"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>All Randomized Participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="486"/>
                    <measurement group_id="B2" value="483"/>
                    <measurement group_id="B3" value="969"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1</title>
        <description>ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
        <time_frame>From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)</time_frame>
        <population>All Intermediate/Poor-Risk Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab + Ipilimumab</title>
            <description>Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1</title>
          <description>ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
          <population>All Intermediate/Poor-Risk Participants</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="425"/>
                <count group_id="O2" value="422"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.6" lower_limit="36.9" upper_limit="46.5"/>
                    <measurement group_id="O2" value="26.5" lower_limit="22.4" upper_limit="31.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>DerSimonian and Laird Test</method>
            <param_type>Stratified Difference</param_type>
            <param_value>16.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.8</ci_lower_limit>
            <ci_upper_limit>22.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</title>
        <description>OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact (&quot;last known alive date&quot;) for subjects who were alive.</description>
        <time_frame>From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)</time_frame>
        <population>All Intermediate/Poor-Risk Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab + Ipilimumab</title>
            <description>Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</title>
          <description>OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact (&quot;last known alive date&quot;) for subjects who were alive.</description>
          <population>All Intermediate/Poor-Risk 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="425"/>
                <count group_id="O2" value="422"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="28.16" upper_limit="NA">The median for Overall Survival and Upper Limit have not been reached. There were an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="25.95" lower_limit="22.08" upper_limit="NA">The median for Overall Survival and Upper Limit have not been reached. There were an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.63</param_value>
            <ci_percent>99.8</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.44</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</title>
        <description>PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.</description>
        <time_frame>From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)</time_frame>
        <population>All Intermediate/Poor-Risk Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab + Ipilimumab</title>
            <description>Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</title>
          <description>PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.</description>
          <population>All Intermediate/Poor-Risk 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="425"/>
                <count group_id="O2" value="422"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.56" lower_limit="8.71" upper_limit="15.51"/>
                    <measurement group_id="O2" value="8.38" lower_limit="7.03" upper_limit="10.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0331</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.82</param_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1</title>
        <description>ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
        <time_frame>From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)</time_frame>
        <population>All Randomized</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab + Ipilimumab</title>
            <description>Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1</title>
          <description>ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
          <population>All Randomized</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="550"/>
                <count group_id="O2" value="546"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7" lower_limit="34.6" upper_limit="42.9"/>
                    <measurement group_id="O2" value="32.2" lower_limit="28.3" upper_limit="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0191</p_value>
            <method>DerSimonian and Laird Test</method>
            <param_type>Stratified Difference</param_type>
            <param_value>7.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.8</ci_lower_limit>
            <ci_upper_limit>12.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</title>
        <description>Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact (&quot;last known alive date&quot;). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after subject's off-treatment date.</description>
        <time_frame>From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)</time_frame>
        <population>All Randomized</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab + Ipilimumab</title>
            <description>Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</title>
          <description>Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact (&quot;last known alive date&quot;). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after subject's off-treatment date.</description>
          <population>All Randomized</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="550"/>
                <count group_id="O2" value="546"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">The median for Overall Survival, Lower limit, and Upper Limit have not been reached. There were an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="32.92" lower_limit="NA" upper_limit="NA">The Lower Limit and Upper Limit have not been reached. With only 1 participant at that time point, the variance is not estimable and so the Confidence Intervals were N/A.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.68</param_value>
            <ci_percent>99.8</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</title>
        <description>PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.</description>
        <time_frame>From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)</time_frame>
        <population>All Randomized</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab + Ipilimumab</title>
            <description>Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)</title>
          <description>PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.</description>
          <population>All Randomized</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="550"/>
                <count group_id="O2" value="546"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.42" lower_limit="9.89" upper_limit="16.53"/>
                    <measurement group_id="O2" value="12.32" lower_limit="9.79" upper_limit="15.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8498</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>99.1</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose to 30 days after last dose of study therapy (assessed up to June 2017, approximately 31 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nivolumab + Ipilimumab</title>
          <description>Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
        </group>
        <group group_id="E2">
          <title>Sunitinib</title>
          <description>Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends&#xD;
After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="159" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="202" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="305" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="213" subjects_at_risk="535"/>
              </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="6" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Autoimmune neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Splenic lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </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="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cardiovascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Adrenocortical insufficiency acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Adrenocorticotropic hormone deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Autoimmune hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Basedow's disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypopituitarism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypothalamo-pituitary disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Secondary adrenocortical insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Steroid withdrawal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Thyroiditis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Inflammation of lacrimal passage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Autoimmune colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Diarrhoea haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Duodenal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Intussusception</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Oesophagitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Gallbladder disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Gallbladder obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hepatic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hepatitis toxic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Portal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </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="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Autoimmune disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Contrast media allergy</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Contrast media reaction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Herpes zoster disseminated</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Meningitis aseptic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Rectal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Drug administration error</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pneumonitis chemical</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Postoperative hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pancreatic enzymes increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </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="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Fulminant type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="535"/>
              </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="4" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Osteolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of jaw</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Gastric adenoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Malignant pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Metastatic neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Metastatic renal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Small intestine adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Central nervous system lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cervical cord compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Embolic cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Facial nerve disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Facial paresis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Iiird nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Intracranial aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Intracranial pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Myasthenia gravis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Speech disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Thecal sac compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device breakage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </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="8" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Autoimmune nephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Nephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Renal injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Renal mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acquired diaphragmatic eventration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Bronchial obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Chylothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hydrothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Laryngeal oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Orthopnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Reflux laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Haemorrhage subcutaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Stevens-johnson syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Immobile</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Angiopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Subclavian vein occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Vein rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="530" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="522" subjects_at_risk="535"/>
              </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="71" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="108" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="73" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="98" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="94" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="144" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="93" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="94" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="198" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="310" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="112" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="67" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="161" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="230" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="152" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="108" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="148" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="88" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="99" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="246" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="291" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="156" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="75" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="66" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="126" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="85" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="96" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="65" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="535"/>
              </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="114" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="156" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="535"/>
              </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="122" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="83" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="87" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="89" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="61" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="185" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="102" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="120" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="535"/>
              </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="144" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="125" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="95" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="92" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="75" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Hair colour changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="237" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="180" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="58" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="139" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="84" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="535"/>
              </event>
              <event>
                <sub_title>Yellow skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="535"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="547"/>
                <counts group_id="E2" subjects_affected="230" subjects_at_risk="535"/>
              </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/NCT02231749
org study id: CA209-214
secondary id: 2014-001750-42
nct id: NCT02231749
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to compare the objective response rate, progression free
      survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib
      monotherapy in patients with previously untreated Renal Cell Cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1
time frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)
description: ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
measure: Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
time frame: From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)
description: OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact ("last known alive date") for subjects who were alive.
measure: Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
time frame: From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)
description: PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.
measure: Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1
time frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)
description: ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
measure: Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
time frame: From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)
description: Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date"). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after subject's off-treatment date.
measure: Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
time frame: From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)
description: PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.
arm group label: Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
arm group type: Experimental
description: Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
arm group label: Arm B: Sunitinib 50 mg
arm group type: Active Comparator
description: Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
intervention type: Biological
intervention name: Nivolumab
arm group label: Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
arm group label: Arm B: Sunitinib 50 mg
other name: BMS-936558
other name: Opdivo
intervention type: Biological
intervention name: Ipilimumab
arm group label: Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
arm group label: Arm B: Sunitinib 50 mg
other name: Yervoy
intervention type: Drug
intervention name: Sunitinib
arm group label: Arm B: Sunitinib 50 mg
other name: Sutent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: Canada
country: Chile
country: Colombia
country: Czechia
country: Denmark
country: Finland
country: France
country: Germany
country: Hungary
country: Ireland
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: Netherlands
country: Poland
country: Spain
country: Sweden
country: Taiwan
country: Turkey
country: United Kingdom
country: United States
country: Czech Republic
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Nivolumab
mesh term: Ipilimumab
mesh term: Sunitinib
provided document: 
provided document: 
participant flow: 
baseline: 
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reported events: 
certain agreements: 
point of contact: 