<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01668784</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-025</org_study_id>
    <secondary_id>2011-005132-26</secondary_id>
    <nct_id>NCT01668784</nct_id>
  </id_info>
  <brief_title>Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)</brief_title>
  <official_title>A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy</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 the study is to compare the clinical benefit, as measured by duration of&#xD;
      overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic&#xD;
      clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2012</start_date>
  <completion_date type="Actual">July 19, 2021</completion_date>
  <primary_completion_date type="Actual">May 6, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</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>Overall Survival (OS) at Primary Endpoint</measure>
    <time_frame>Randomization until 398 deaths, up to May 2015 (approximately 30 months)</time_frame>
    <description>Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p &lt; 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator-assessed Objective Response Rate (ORR)</measure>
    <time_frame>from randomization up to disease progression or death (approximately up to 105 Months)</time_frame>
    <description>ORR is defined as Percentage of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator-assessed Duration of Objective Response</measure>
    <time_frame>From randomization to date of disease progression or death or censoring if no progression or death occurred (approximately 105 months)</time_frame>
    <description>Duration of objective response is defined as the time from study start date to response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Based on Kaplan-Meier Estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator-assessed Time to Objective Response</measure>
    <time_frame>Randomization to date of first response (approximately 105 months)</time_frame>
    <description>Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator-assessed Time of Progression-free Survival (PFS)</measure>
    <time_frame>from randomization up to disease progression or death (approximately up to 105 Months)</time_frame>
    <description>PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: &gt;=20% increase in sum of target lesion diameters and sum must show absolute increase of &gt;=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level</measure>
    <time_frame>Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)</time_frame>
    <description>Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H&amp;E process before the tumor biopsy specimen was sent for evaluation or from H&amp;E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events</measure>
    <time_frame>Day of first dose to 30 days post study completion (approximately 106 months)</time_frame>
    <description>Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Disease-related Symptom Progression (DRSP)</measure>
    <time_frame>from randomization up to disease progression or death (approximately up to 105 Months)</time_frame>
    <description>Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests</measure>
    <time_frame>Day 1 to 30 days post study completion (approximately 106 months)</time_frame>
    <description>Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units</measure>
    <time_frame>Day 1 to 30 days post study completion (approximately 106 months)</time_frame>
    <description>Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: &lt; 8.0 g/dL), Platelet Count (Gr 3: 25.0 -&lt; 50.0*10^9 c/L; Gr 4: &lt; 25.0*10^9 c/L), Leukocyte Count (Gr 3: 1.0 -&lt; 2.0*10^3 c/µL; Gr4: &lt; 1.0*10^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -&lt; 0.5*10^3 c/µL; Gr 4: &lt; 0.2*10^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - &lt; 1.0*10^3 c/µL; Gr 4: &lt; 0.5*10^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: &gt; 5.0 - 20.0 U/L * ULN; Gr 4: &gt; 20.0 U/L * ULN), AST (Gr 3: &gt; 5.0 - 20.0 U/L * ULN; Gr 4: &gt; 20.0 U/L * ULN), ALT (Gr 3: &gt; 5.0 - 20.0 U/L * ULN; Gr 4: &gt; 20.0 U/L * ULN), tBIL (Gr 3: &gt; 3.0 - 10.0 mg/dL * ULN; Gr 4: &gt; 10.0 mg/dL * ULN). Renal parameter=Creatinine (Grade: Gr3: &gt; 3.0 - 6.0 mg/dL *ULN; Gr4: &gt; 6.0 mg/dL *ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">821</enrollment>
  <condition>Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm 1: Nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab 3 mg/kg solution 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 2: Everolimus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Everolimus 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <arm_group_label>Arm 1: Nivolumab</arm_group_label>
    <other_name>BMS-936558</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Everolimus</intervention_name>
    <arm_group_label>Arm 2: Everolimus</arm_group_label>
    <other_name>Afinitor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men &amp; women ≥18 years of age&#xD;
&#xD;
          -  Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component&#xD;
&#xD;
          -  Advanced/metastatic RCC&#xD;
&#xD;
          -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1&#xD;
             criteria&#xD;
&#xD;
          -  Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic&#xD;
             setting&#xD;
&#xD;
          -  No more than 3 total prior systemic treatment regimens in the advanced or metastatic&#xD;
             setting, and evidence of progression on or after last treatment regimen received and&#xD;
             within 6 months of enrollment&#xD;
&#xD;
          -  Karnofsky Performance Score ≥70%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any Central Nervous System (CNS) metastases or history of CNS metastases&#xD;
&#xD;
          -  Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor&#xD;
&#xD;
          -  Any active known or suspected autoimmune disease&#xD;
&#xD;
          -  Uncontrolled adrenal insufficiency&#xD;
&#xD;
          -  Active chronic liver disease&#xD;
&#xD;
          -  Prior malignancy active within past 3 years, except for locally curable cancers&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution - 0182</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSD Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093-0698</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0024</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ucsf Helen Diller Family Comprehensive Cancer Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Institute</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0027</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center &amp; Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612-9497</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Chicago</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Iowa Hospitals And Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231-1000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5946</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Francis Hospital</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-6307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ut Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0139</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-4009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTRC at UTHSC San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0076</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0009</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>COIBA</name>
      <address>
        <city>Berazategui</city>
        <state>Buenos Aires</state>
        <zip>1880</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Capital Federal</city>
        <state>Buenos Aires</state>
        <zip>1431</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Para La Atencion Integral Del Paciente Oncologico</name>
      <address>
        <city>San Miguel De Tucuman</city>
        <state>Tucuman</state>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1280AEB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1426ANZ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Oncologico De Cordoba</name>
      <address>
        <city>Cordoba</city>
        <zip>X5006HBF</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0095</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Woodville South</city>
        <state>South Australia</state>
        <zip>5011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wien</city>
        <zip>1130</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0125</name>
      <address>
        <city>Ijui</city>
        <state>RIO Grande DO SUL</state>
        <zip>98700-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0124</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01321-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Cancer Agency - Vancouver Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre D'Oncologie Dr-Leon-Richard</name>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <zip>E1C 8X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QEII Health Sciences Centre</name>
      <address>
        <city>Halfax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0143</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chum, Hopital Notre-Dame</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0145</name>
      <address>
        <city>Montreal</city>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Prague 5</city>
        <zip>150 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</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</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0006</name>
      <address>
        <city>Vandoeuvre-lès-Nancy</city>
        <state>Lorraine</state>
        <zip>54519</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0008</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0007</name>
      <address>
        <city>Lyon Cedex</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Lyon Cedex</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0004</name>
      <address>
        <city>Marseille Cedex 9</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Marseille Cedex 9</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0118</name>
      <address>
        <city>Paris</city>
        <zip>75908</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0003</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0005</name>
      <address>
        <city>Saint Herblain Cedex</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Saint Herblain Cedex</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0012</name>
      <address>
        <city>Toulouse Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Toulouse Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0002</name>
      <address>
        <city>Villejuif Cedex</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Villejuif Cedex</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0126</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandra General Hospital Of Athens</name>
      <address>
        <city>Athens</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Euromedica General Clinic of Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54645</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tallaght</city>
        <state>Dublin</state>
        <zip>DUBLIN 24</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0087</name>
      <address>
        <city>Dublin</city>
        <zip>7</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 7</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0148</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Ramat-gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Arezzo</city>
        <zip>52100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Meldola (fc)</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0082</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Rimini</city>
        <zip>47900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Roma</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Roma</city>
        <zip>00152</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0102</name>
      <address>
        <city>Rozzano</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Terni</city>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Akita-shi</city>
        <state>Akita</state>
        <zip>0108543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <zip>2608717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Higashi-ku</city>
        <state>Fukuoka</state>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sapporo-city</city>
        <state>Hokkaido</state>
        <zip>0608543</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</name>
      <address>
        <city>Morioka-shi</city>
        <state>Iwate</state>
        <zip>0208505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>2360004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Osaka-sayama-shi</city>
        <state>Osaka</state>
        <zip>5898511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0169</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>5650871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0167</name>
      <address>
        <city>Hamamatsu-shi</city>
        <state>Shizuoka</state>
        <zip>4313192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tokushima-shi</city>
        <state>Tokushima</state>
        <zip>7708503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Yamagata-shi</city>
        <state>Yamagata</state>
        <zip>9909585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kobe-city, Hyogo</city>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kumamoto</city>
        <zip>860-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tokyo</city>
        <zip>1138603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tokyo</city>
        <zip>1138655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tokyo</city>
        <zip>1358550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tokyo</city>
        <zip>1608582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tokyo</city>
        <zip>1628666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tokyo</city>
        <zip>1738606</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Lorenskog</city>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Gdansk</city>
        <zip>80-219</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Lodz</city>
        <zip>93-513</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Poznan</city>
        <zip>60-569</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Rybnik</city>
        <zip>44-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Warszawa</city>
        <zip>00-909</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-556</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bucharest</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Craiova</city>
        <zip>200385</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Iasi</city>
        <zip>700106</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Timisoara</city>
        <zip>300167</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Moscow</city>
        <zip>121309</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>St Petersburg</city>
        <zip>198255</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0064</name>
      <address>
        <city>Hospitalet De Llobregat</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Gothenberg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Solna</city>
        <zip>171 64</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0048</name>
      <address>
        <city>Swansea</city>
        <state>Carmarthenshire</state>
        <zip>SA2 8QA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Swansea</city>
        <state>Carmarthenshire</state>
        <zip>SA2 8QA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>SW3 6JJ</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>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Hungary</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>July 2022</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <results_first_submitted>March 28, 2016</results_first_submitted>
  <results_first_submitted_qc>April 28, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 29, 2016</results_first_posted>
  <last_update_submitted>July 15, 2022</last_update_submitted>
  <last_update_submitted_qc>July 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</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>Everolimus</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>803 Participants Treated</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Nivolumab</title>
          <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
          <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Randomized (Pre-treatment)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="410"/>
                <participants group_id="P2" count="411"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="406"/>
                <participants group_id="P2" count="397"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Request to Discontinue Study Treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor/Non-Compliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No Longer Meets Study Criteria</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>participant requested to be treated a local facility</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="406"/>
                <participants group_id="P2" count="397"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="406"/>
                <participants group_id="P2" count="397"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="316"/>
                <participants group_id="P2" count="293"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Drug Toxicity</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="53"/>
              </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>Adverse Event Unrelated to Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Request to Discontinue Study Treatment</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Maximal Clinical Benefit</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Administrative Reason by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants; any participant that was randomized to any treatment group in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Nivolumab</title>
          <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
          <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</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="410"/>
            <count group_id="B2" value="411"/>
            <count group_id="B3" value="821"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.6" spread="10.87"/>
                    <measurement group_id="B2" value="61.9" spread="10.43"/>
                    <measurement group_id="B3" value="61.3" spread="10.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="202"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="315"/>
                    <measurement group_id="B2" value="304"/>
                    <measurement group_id="B3" value="619"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="353"/>
                    <measurement group_id="B2" value="367"/>
                    <measurement group_id="B3" value="720"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS) at Primary Endpoint</title>
        <description>Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p &lt; 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria.</description>
        <time_frame>Randomization until 398 deaths, up to May 2015 (approximately 30 months)</time_frame>
        <population>All randomized participants; any participants that was randomized to any treatment group in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
            <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) at Primary Endpoint</title>
          <description>Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p &lt; 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria.</description>
          <population>All randomized participants; any participants that was randomized to any treatment group in the study.</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="410"/>
                <count group_id="O2" value="411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.00" lower_limit="21.75" upper_limit="NA">N.A.: Not Available: Too few events to estimate the upper limit of the confidence interval</measurement>
                    <measurement group_id="O2" value="19.55" lower_limit="17.64" upper_limit="23.06"/>
                  </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>0.0018</p_value>
            <p_value_desc>The boundary for statistical significance required the p-value to be less than 0.0148 at the interim analyses.</p_value_desc>
            <method>Log Rank</method>
            <method_desc>Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center risk group, number of prior anti-angiogenic therapies, and the region.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>98.52</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
            <estimate_desc>Stratified Cox proportional hazard model. Hazard ratio (HR) was Nivolumab over Everolimus.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator-assessed Objective Response Rate (ORR)</title>
        <description>ORR is defined as Percentage of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.</description>
        <time_frame>from randomization up to disease progression or death (approximately up to 105 Months)</time_frame>
        <population>All randomized participants; any participants that was randomized to any treatment group in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
            <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator-assessed Objective Response Rate (ORR)</title>
          <description>ORR is defined as Percentage of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.</description>
          <population>All randomized participants; any participants that was randomized to any treatment group in the study.</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="410"/>
                <count group_id="O2" value="411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" lower_limit="21.7" upper_limit="30.4"/>
                    <measurement group_id="O2" value="6.1" lower_limit="4.0" upper_limit="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator-assessed Duration of Objective Response</title>
        <description>Duration of objective response is defined as the time from study start date to response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Based on Kaplan-Meier Estimates.</description>
        <time_frame>From randomization to date of disease progression or death or censoring if no progression or death occurred (approximately 105 months)</time_frame>
        <population>All randomized participants with a response; any participants that were randomized to any treatment group in the study and that had a response.</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
            <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator-assessed Duration of Objective Response</title>
          <description>Duration of objective response is defined as the time from study start date to response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Based on Kaplan-Meier Estimates.</description>
          <population>All randomized participants with a response; any participants that were randomized to any treatment group in the study and that had a response.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.11" lower_limit="9.26" upper_limit="19.75"/>
                    <measurement group_id="O2" value="10.18" lower_limit="5.39" upper_limit="18.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator-assessed Time to Objective Response</title>
        <description>Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference.</description>
        <time_frame>Randomization to date of first response (approximately 105 months)</time_frame>
        <population>All randomized participants with a response; any participants that was randomized to any treatment group in the study and that had a response.</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
            <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator-assessed Time to Objective Response</title>
          <description>Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference.</description>
          <population>All randomized participants with a response; any participants that was randomized to any treatment group in the study and that had a response.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.55" lower_limit="1.4" upper_limit="24.8"/>
                    <measurement group_id="O2" value="3.71" lower_limit="1.5" upper_limit="68.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator-assessed Time of Progression-free Survival (PFS)</title>
        <description>PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: &gt;=20% increase in sum of target lesion diameters and sum must show absolute increase of &gt;=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.</description>
        <time_frame>from randomization up to disease progression or death (approximately up to 105 Months)</time_frame>
        <population>All randomized participants; any participants that was randomized to any treatment group in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
            <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator-assessed Time of Progression-free Survival (PFS)</title>
          <description>PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: &gt;=20% increase in sum of target lesion diameters and sum must show absolute increase of &gt;=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.</description>
          <population>All randomized participants; any participants that was randomized to any treatment group in the study.</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="410"/>
                <count group_id="O2" value="411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.21" lower_limit="3.68" upper_limit="5.36"/>
                    <measurement group_id="O2" value="4.50" lower_limit="3.71" upper_limit="5.52"/>
                  </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>0.0340</p_value>
            <method>Log Rank</method>
            <method_desc>Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group, number of prior anti-angiogenic therapies, and the region.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
            <estimate_desc>Stratified Cox proportional hazard model. Hazard ratio is nivolumab over everolimus.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level</title>
        <description>Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H&amp;E process before the tumor biopsy specimen was sent for evaluation or from H&amp;E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.</description>
        <time_frame>Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)</time_frame>
        <population>PD-L1 quantifiable participants; All randomized participants with quantifiable PD-L1 expression at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
            <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level</title>
          <description>Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H&amp;E process before the tumor biopsy specimen was sent for evaluation or from H&amp;E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.</description>
          <population>PD-L1 quantifiable participants; All randomized participants with quantifiable PD-L1 expression at baseline</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="370"/>
                <count group_id="O2" value="386"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participant PD-L1 expression &gt;=1%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.36" lower_limit="2.04" upper_limit="7.46"/>
                    <measurement group_id="O2" value="4.17" lower_limit="3.09" upper_limit="5.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant PD-L1 expression &lt;1%</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="299"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.94" lower_limit="3.68" upper_limit="5.36"/>
                    <measurement group_id="O2" value="4.67" lower_limit="3.71" upper_limit="5.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events</title>
        <description>Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.</description>
        <time_frame>Day of first dose to 30 days post study completion (approximately 106 months)</time_frame>
        <population>All treated participants; all participants who received at least one dose of nivolumab or everolimus</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
            <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events</title>
          <description>Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.</description>
          <population>All treated participants; all participants who received at least one dose of nivolumab or everolimus</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="406"/>
                <count group_id="O2" value="397"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="324"/>
                    <measurement group_id="O2" value="342"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211"/>
                    <measurement group_id="O2" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="327"/>
                    <measurement group_id="O2" value="353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinued due to Drug-related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinued due to AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="398"/>
                    <measurement group_id="O2" value="387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Disease-related Symptom Progression (DRSP)</title>
        <description>Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.</description>
        <time_frame>from randomization up to disease progression or death (approximately up to 105 Months)</time_frame>
        <population>All randomized participants; any participants that was randomized to any treatment group in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
            <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease-related Symptom Progression (DRSP)</title>
          <description>Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.</description>
          <population>All randomized participants; any participants that was randomized to any treatment group in the study.</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="410"/>
                <count group_id="O2" value="411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Disease-related Symptom Progression Rate (DRSPR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.6" lower_limit="39.0" upper_limit="50.3"/>
                    <measurement group_id="O2" value="54.6" lower_limit="49.2" upper_limit="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DRSPR Including Death and Investigator Progression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5" lower_limit="92.6" upper_limit="97.5"/>
                    <measurement group_id="O2" value="99.4" lower_limit="97.9" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests</title>
        <description>Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).</description>
        <time_frame>Day 1 to 30 days post study completion (approximately 106 months)</time_frame>
        <population>To all treated participants with evaluable measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
            <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests</title>
          <description>Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).</description>
          <population>To all treated participants with evaluable measurements</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="406"/>
                <count group_id="O2" value="397"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT or AST &gt; 3.0*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="401"/>
                    <count group_id="O2" value="377"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT or AST &gt; 5.0*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="401"/>
                    <count group_id="O2" value="377"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT or AST &gt; 10.0*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="401"/>
                    <count group_id="O2" value="377"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT or AST &gt; 20.0*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="401"/>
                    <count group_id="O2" value="377"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin &gt; 2.0*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="401"/>
                    <count group_id="O2" value="376"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT or AST&gt;3.0*ULN, tBIL&gt;2.0 ULN, 1day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="401"/>
                    <count group_id="O2" value="376"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT or AST&gt;3.0*ULN, tBIL&gt;2.0 ULN,30day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="401"/>
                    <count group_id="O2" value="376"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &gt; ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="382"/>
                    <count group_id="O2" value="361"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TSH &lt; LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="382"/>
                    <count group_id="O2" value="361"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units</title>
        <description>Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: &lt; 8.0 g/dL), Platelet Count (Gr 3: 25.0 -&lt; 50.0*10^9 c/L; Gr 4: &lt; 25.0*10^9 c/L), Leukocyte Count (Gr 3: 1.0 -&lt; 2.0*10^3 c/µL; Gr4: &lt; 1.0*10^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -&lt; 0.5*10^3 c/µL; Gr 4: &lt; 0.2*10^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - &lt; 1.0*10^3 c/µL; Gr 4: &lt; 0.5*10^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: &gt; 5.0 - 20.0 U/L * ULN; Gr 4: &gt; 20.0 U/L * ULN), AST (Gr 3: &gt; 5.0 - 20.0 U/L * ULN; Gr 4: &gt; 20.0 U/L * ULN), ALT (Gr 3: &gt; 5.0 - 20.0 U/L * ULN; Gr 4: &gt; 20.0 U/L * ULN), tBIL (Gr 3: &gt; 3.0 - 10.0 mg/dL * ULN; Gr 4: &gt; 10.0 mg/dL * ULN). Renal parameter=Creatinine (Grade: Gr3: &gt; 3.0 - 6.0 mg/dL *ULN; Gr4: &gt; 6.0 mg/dL *ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).</description>
        <time_frame>Day 1 to 30 days post study completion (approximately 106 months)</time_frame>
        <population>To all treated participants with evaluable measurements</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
            <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units</title>
          <description>Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: &lt; 8.0 g/dL), Platelet Count (Gr 3: 25.0 -&lt; 50.0*10^9 c/L; Gr 4: &lt; 25.0*10^9 c/L), Leukocyte Count (Gr 3: 1.0 -&lt; 2.0*10^3 c/µL; Gr4: &lt; 1.0*10^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -&lt; 0.5*10^3 c/µL; Gr 4: &lt; 0.2*10^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - &lt; 1.0*10^3 c/µL; Gr 4: &lt; 0.5*10^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: &gt; 5.0 - 20.0 U/L * ULN; Gr 4: &gt; 20.0 U/L * ULN), AST (Gr 3: &gt; 5.0 - 20.0 U/L * ULN; Gr 4: &gt; 20.0 U/L * ULN), ALT (Gr 3: &gt; 5.0 - 20.0 U/L * ULN; Gr 4: &gt; 20.0 U/L * ULN), tBIL (Gr 3: &gt; 3.0 - 10.0 mg/dL * ULN; Gr 4: &gt; 10.0 mg/dL * ULN). Renal parameter=Creatinine (Grade: Gr3: &gt; 3.0 - 6.0 mg/dL *ULN; Gr4: &gt; 6.0 mg/dL *ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).</description>
          <population>To all treated participants with evaluable measurements</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="406"/>
                <count group_id="O2" value="397"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="395"/>
                    <count group_id="O2" value="383"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="391"/>
                    <count group_id="O2" value="379"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count, Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="391"/>
                    <count group_id="O2" value="379"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="394"/>
                    <count group_id="O2" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="394"/>
                    <count group_id="O2" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (absolute), Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="391"/>
                    <count group_id="O2" value="377"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (absolute), Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="391"/>
                    <count group_id="O2" value="377"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Neutrophil Count, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="392"/>
                    <count group_id="O2" value="378"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Neutrophil Count, Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="392"/>
                    <count group_id="O2" value="378"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="400"/>
                    <count group_id="O2" value="374"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="400"/>
                    <count group_id="O2" value="375"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase, Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="400"/>
                    <count group_id="O2" value="375"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="401"/>
                    <count group_id="O2" value="376"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase, Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="401"/>
                    <count group_id="O2" value="376"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin Total, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="401"/>
                    <count group_id="O2" value="376"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="398"/>
                    <count group_id="O2" value="379"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="398"/>
                    <count group_id="O2" value="379"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypercalcemia, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="339"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypercalcemia, Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="339"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypocalcemia, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="339"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypocalcemia, Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="339"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperkalemia, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="352"/>
                    <count group_id="O2" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperkalemia, Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="352"/>
                    <count group_id="O2" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypokalemia, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="352"/>
                    <count group_id="O2" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypermagnesmia, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="196"/>
                    <count group_id="O2" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypomagnesmia, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="196"/>
                    <count group_id="O2" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyponatremia, Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="353"/>
                    <count group_id="O2" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyponatremia, Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="353"/>
                    <count group_id="O2" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Extended Collection to Post Hoc Overall Survival (OS)</title>
        <description>Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p &lt; 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria.&#xD;
This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.</description>
        <time_frame>from randomization up to disease progression or death (approximately up to 105 months)</time_frame>
        <population>All Randomized Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Nivolumab</title>
            <description>Nivolumab at 3 mg/kg solution provided 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>Everolimus</title>
            <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Extended Collection to Post Hoc Overall Survival (OS)</title>
          <description>Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p &lt; 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria.&#xD;
This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date.</description>
          <population>All Randomized Participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="410"/>
                <count group_id="O2" value="411"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.82" lower_limit="22.21" upper_limit="29.77"/>
                    <measurement group_id="O2" value="19.55" lower_limit="17.64" upper_limit="21.88"/>
                  </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>0.0001</p_value>
            <method>Log Rank</method>
            <param_type>Stratified Cox Proportional hazard Model</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality was assessed from first dose to study completion (up to 105 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (approximately up to 107 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>NIVOLUMAB</title>
          <description>Nivolumab at 3 mg/kg solution provided 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>EVEROLIMUS</title>
          <description>Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="324" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="342" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="248" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="243" subjects_at_risk="397"/>
              </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="9" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Methaemoglobinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </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="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cardiac ventricular thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreas divisum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tympanic membrane perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia of malignancy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypopituitarism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </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="406"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Autoimmune colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Diabetic gastroparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Haemoperitoneum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Immune-mediated enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Intra-abdominal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Oesophageal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pneumoperitoneum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Small intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </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="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hernia pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hyperpyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Inadequate analgesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Performance status decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Biliary obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hepatic cytolysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hepatic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hepatorenal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Immune-mediated hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </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="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Brain abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Febrile infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Genital infection fungal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Groin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Lymphangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Peritonitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pneumonia mycoplasmal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Psoas abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Spinal cord infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Splenic infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Cervical vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Incision site impaired healing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Post procedural swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Product administration error</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Wound complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Blood culture positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>General physical condition abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pancreatic enzymes increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Viral test positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Cachexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Glucose tolerance impaired</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </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="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Back disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Bone disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Bone lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Osteitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Osteolysis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of jaw</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Soft tissue necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acoustic neuroma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Acute lymphocytic leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Duodenal neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Intracranial tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Lymphangiosis carcinomatosa</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Malignant melanoma in situ</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="85" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Metastases to abdominal cavity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Metastases to adrenals</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Metastases to lung</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Metastases to pancreas</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Metastases to peritoneum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Metastases to spine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Metastases to thyroid</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Metastatic neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Metastatic renal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Oesophageal adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma recurrent</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Skin cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Central nervous system haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dural arteriovenous fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Facial spasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hyperammonaemic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Immune-mediated encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Intracranial pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Intraventricular haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Nervous system disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Thalamus haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Vasogenic cerebral oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device loosening</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Mental disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </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="12" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Renal mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Renal tubular necrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Bronchial obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pulmonary infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acute febrile neutrophilic dermatosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic dissection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="392" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="379" subjects_at_risk="397"/>
              </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="93" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="149" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="110" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="93" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="122" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="141" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="135" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="139" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="125" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="77" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="80" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="71" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="215" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="196" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="89" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="73" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="110" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="81" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="84" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="61" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="67" subjects_at_risk="397"/>
              </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="109" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="145" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="66" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="77" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="397"/>
              </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="120" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="79" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="99" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="77" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="66" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Taste disorder</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="397"/>
              </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="146" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="152" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="101" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="114" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="66" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="64" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="86" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="101" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="397"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="397"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="406"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="397"/>
              </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>
      <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/NCT01668784
org study id: CA209-025
secondary id: 2011-005132-26
nct id: NCT01668784
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to compare the clinical benefit, as measured by duration of
      overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic
      clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS) at Primary Endpoint
time frame: Randomization until 398 deaths, up to May 2015 (approximately 30 months)
description: Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p < 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria.
measure: Investigator-assessed Objective Response Rate (ORR)
time frame: from randomization up to disease progression or death (approximately up to 105 Months)
description: ORR is defined as Percentage of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.
measure: Investigator-assessed Duration of Objective Response
time frame: From randomization to date of disease progression or death or censoring if no progression or death occurred (approximately 105 months)
description: Duration of objective response is defined as the time from study start date to response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Based on Kaplan-Meier Estimates.
measure: Investigator-assessed Time to Objective Response
time frame: Randomization to date of first response (approximately 105 months)
description: Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference.
measure: Investigator-assessed Time of Progression-free Survival (PFS)
time frame: from randomization up to disease progression or death (approximately up to 105 Months)
description: PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: >=20% increase in sum of target lesion diameters and sum must show absolute increase of >=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.
measure: Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level
time frame: Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)
description: Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H&E process before the tumor biopsy specimen was sent for evaluation or from H&E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.
measure: Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events
time frame: Day of first dose to 30 days post study completion (approximately 106 months)
description: Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
measure: Percentage of Participants With Disease-related Symptom Progression (DRSP)
time frame: from randomization up to disease progression or death (approximately up to 105 Months)
description: Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.
measure: Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests
time frame: Day 1 to 30 days post study completion (approximately 106 months)
description: Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).
measure: Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units
time frame: Day 1 to 30 days post study completion (approximately 106 months)
description: Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: < 8.0 g/dL), Platelet Count (Gr 3: 25.0 -< 50.0*10^9 c/L; Gr 4: < 25.0*10^9 c/L), Leukocyte Count (Gr 3: 1.0 -< 2.0*10^3 c/µL; Gr4: < 1.0*10^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -< 0.5*10^3 c/µL; Gr 4: < 0.2*10^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - < 1.0*10^3 c/µL; Gr 4: < 0.5*10^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), AST (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), ALT (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), tBIL (Gr 3: > 3.0 - 10.0 mg/dL * ULN; Gr 4: > 10.0 mg/dL * ULN). Renal parameter=Creatinine (Grade: Gr3: > 3.0 - 6.0 mg/dL *ULN; Gr4: > 6.0 mg/dL *ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).
arm group label: Arm 1: Nivolumab
arm group type: Experimental
description: Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
arm group label: Arm 2: Everolimus
arm group type: Active Comparator
description: Everolimus 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
intervention type: Biological
intervention name: Nivolumab
arm group label: Arm 1: Nivolumab
other name: BMS-936558
intervention type: Drug
intervention name: Everolimus
arm group label: Arm 2: Everolimus
other name: Afinitor
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: Czechia
country: Denmark
country: Finland
country: France
country: Germany
country: Greece
country: Ireland
country: Israel
country: Italy
country: Japan
country: Norway
country: Poland
country: Romania
country: Russian Federation
country: Spain
country: Sweden
country: United Kingdom
country: United States
country: Czech Republic
country: Hungary
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: Everolimus
participant flow: 
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reported events: 
certain agreements: 
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