<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/NCT03024996</url>
  </required_header>
  <id_info>
    <org_study_id>WO39210</org_study_id>
    <secondary_id>2016-001881-27</secondary_id>
    <nct_id>NCT03024996</nct_id>
  </id_info>
  <brief_title>A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy</brief_title>
  <acronym>IMmotion010</acronym>
  <official_title>A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to&#xD;
      evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who&#xD;
      are at high risk of disease recurrence following nephrectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The sponsor decided to terminate this study before the protocol-defined end-of-study, as&#xD;
    permitted per protocol.&#xD;
  </why_stopped>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">December 8, 2022</completion_date>
  <primary_completion_date type="Actual">May 3, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Investigator-assessed Disease-Free Survival (DFS)</measure>
    <time_frame>From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)</time_frame>
    <description>Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From baseline up to death due to any cause (up to approximately 64 months)</time_frame>
    <description>OS was defined as the time from randomization to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3</measure>
    <time_frame>From baseline until first occurrence of DFS event (up to approximately 64 months)</time_frame>
    <description>Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as &lt;1% and IC1/2/3 was defined as &gt;=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Independent Review Facility (IRF)-Assessed DFS</measure>
    <time_frame>From baseline until first documented recurrence event (up to approximately 64 months)</time_frame>
    <description>IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3</measure>
    <time_frame>From baseline until first occurrence of DFS event (up to approximately 64 months)</time_frame>
    <description>IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as &lt;1% and IC1/2/3 was defined as &gt;=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IRF-assessed Event-free Survival (EFS)</measure>
    <time_frame>From baseline until first documented recurrence event (up to approximately 64 months)</time_frame>
    <description>IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-Specific Survival</measure>
    <time_frame>From baseline up to death due to RCC (up to approximately 64 months)</time_frame>
    <description>Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant Metastasis-Free Survival</measure>
    <time_frame>From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)</time_frame>
    <description>Distant metastasis-free survival, defined as the time from randomization to death from any cause or the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator, whichever occurred first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events</measure>
    <time_frame>From baseline up to death due to any cause (up to approximately 71 months)</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Serum Concentration (Cmax) of Atezolizumab</measure>
    <time_frame>Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Serum Concentration (Cmin) of Atezolizumab</measure>
    <time_frame>Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab</measure>
    <time_frame>Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">778</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Atezolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab 1200 mg IV infusion q3w</description>
    <arm_group_label>Atezolizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching to atezolizumab q3w</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ECOG performance status of less than or equal to (&lt;/=) 1&#xD;
&#xD;
          -  Pathologically confirmed RCC with a component of either clear cell histology or&#xD;
             sarcomatoid histology that has not been previously treated in the adjuvant or&#xD;
             neoadjuvant setting and classified as being at high risk of RCC recurrence&#xD;
&#xD;
          -  Radical or partial nephrectomy with lymphadenectomy in select participants&#xD;
&#xD;
          -  Absence of residual disease and absence of metastasis, as confirmed by a negative&#xD;
             baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4&#xD;
             weeks prior to randomization. Confirmation of disease-free status will be assessed by&#xD;
             an independent central radiologic review of imaging data.&#xD;
&#xD;
          -  Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic&#xD;
             resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to&#xD;
             randomization. Applicable only to metastasectomy participants&#xD;
&#xD;
          -  Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization&#xD;
             following surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau&#xD;
&#xD;
          -  Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3&#xD;
             weeks prior to initiation of study treatment&#xD;
&#xD;
          -  Treatment with any other investigational agent or participation in another clinical&#xD;
             study with therapeutic intent within 28 days or five half-lives of the investigational&#xD;
             agent, whichever is longer, prior to enrollment&#xD;
&#xD;
          -  Malignancies other than RCC within 5 years prior to Cycle 1, Day 1&#xD;
&#xD;
          -  History of autoimmune disease&#xD;
&#xD;
          -  Participants with prior allogeneic stem cell or solid organ transplantation&#xD;
&#xD;
          -  History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced&#xD;
             pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic&#xD;
             organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan&#xD;
&#xD;
          -  Positive test for HIV&#xD;
&#xD;
          -  Participants with active hepatitis B or hepatitis C&#xD;
&#xD;
          -  Active tuberculosis&#xD;
&#xD;
          -  Severe infections within 4 weeks prior to randomization including but not limited to&#xD;
             hospitalization for complications of infection, bacteremia, or severe pneumonia&#xD;
&#xD;
          -  Major surgical procedure within 4 weeks prior to randomization or anticipation of need&#xD;
             for a major surgical procedure during the course of the study other than for diagnosis&#xD;
&#xD;
          -  Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1&#xD;
&#xD;
          -  Any other diseases, metabolic dysfunction, physical examination finding, or clinical&#xD;
             laboratory finding giving reasonable suspicion of a disease or condition that&#xD;
             contraindicates the use of an investigational drug or that may affect the&#xD;
             interpretation of the results or render the participant at high risk from treatment&#xD;
             complications&#xD;
&#xD;
          -  Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic&#xD;
             T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1),&#xD;
             or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or&#xD;
             pathway-targeting agents&#xD;
&#xD;
          -  Treatment with systemic immunostimulatory agents (including but not limited to&#xD;
             interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever&#xD;
             is shorter, prior to randomization&#xD;
&#xD;
          -  Treatment with systemic immunosuppressive medications (including but not limited to&#xD;
             corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and&#xD;
             anti-tumor necrosis factor agents) within 2 weeks prior to randomization or&#xD;
             anticipated need for systemic immunosuppressive medications during the study&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic- Scottsdale</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope, Antelope Valley</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Urology; Urology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Irvine Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope-South Pasadena</name>
      <address>
        <city>South Pasadena</city>
        <state>California</state>
        <zip>91030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope; Upland</name>
      <address>
        <city>Upland</city>
        <state>California</state>
        <zip>91786</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists-Broadway, Fort Myers</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ of Miami, School of Med; Hem/Onc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Uni - Winship Cancer Center; Hematology/Oncology</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center, Cardinal Bernardin Cancer Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60151</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane Uni Health Sciences Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Urology Research Associates</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Garden State Urology</name>
      <address>
        <city>Whippany</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Oncology Hematology at Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellevue Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laura and ISAAC Perlmutter Cancer Center at NYU Langone.</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount SInai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center; Urology</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</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>Fairview Hospital; Cleveland Clinic Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation; Hematology and Oncology</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillcrest Hospital; Hirsch Cancer Center</name>
      <address>
        <city>Mayfield Heights</city>
        <state>Ohio</state>
        <zip>44124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma; Stephenson Oklahoma Canc Ctr</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science Uni</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center; Hematology/Oncology</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Cancer Cnt Onco Clinic</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erlanger Health Systems</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Associates of Kingsport, P.C.</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</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; Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-4095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah; Huntsman Cancer Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Hospitals Inc</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Britanico; Oncologia</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1280AEB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Aleman</name>
      <address>
        <city>Caba</city>
        <zip>C1118AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico Riojano Integral (CORI)</name>
      <address>
        <city>La Rioja</city>
        <zip>F5300COE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calvary Mater Newcastle; Medical Oncology</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane &amp; Women's Hosp; Cancer Care Serv</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashford Cancer Center Research</name>
      <address>
        <city>Kurralta Park</city>
        <state>South Australia</state>
        <zip>5037</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Hospital; Medical Oncology</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires St-Luc</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Erasto Gaertner</name>
      <address>
        <city>Curitiba</city>
        <state>PR</state>
        <zip>81520-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas - UFRGS</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sao Lucas - PUCRS</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto do Cancer do Estado de Sao Paulo - ICESP</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alemao Oswaldo Cruz</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01323-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre-Calgary</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 ? Kelowna (Sindi Ahluwalia Hawkins Centre)</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 5L3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre; Oncology</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital Cancer Centre; Oncology</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North York General Hospital; Inpatient Pharmacy</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M2K 1E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Odette Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Center</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre - Glen Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec</name>
      <address>
        <city>Quebec</city>
        <zip>G1R 3S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Hill Centro de Investigaciones Clinicas</name>
      <address>
        <city>Recoleta</city>
        <zip>8420383</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sociedad de Investigaciones Medicas Ltda (SIM)</name>
      <address>
        <city>Temuco</city>
        <zip>4800827</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ONCOCENTRO APYS; Oncología</name>
      <address>
        <city>Vina Del Mar</city>
        <zip>2520598</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Cancer Hospital</name>
      <address>
        <city>Nanjing City</city>
        <zip>211100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center; Medical Oncology</name>
      <address>
        <city>Shanghai City</city>
        <zip>201315</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Masarykuv onkologicky ustav</name>
      <address>
        <city>Brno</city>
        <zip>656 53</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Olomouc; Onkologicka klinika</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General University Hospital; CLINIC OF ONCOLOGY</name>
      <address>
        <city>Praha 2</city>
        <zip>128 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomayerova nemocnice</name>
      <address>
        <city>Praha 4 - Krc</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitetshospital; Kræftafdelingen</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev Hospital; Afdeling for Kræftbehandling</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <zip>49033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Henri Mondor; Service d'Oncologie Medicale</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes - Hotel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris; Oncologie</name>
      <address>
        <city>Paris</city>
        <zip>75674</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen - Hôpital Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nouvel Hopital Civil - CHU Strasbourg; Urologie</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum &quot;Carl Gustav Carus&quot;; Klinik und Poliklinik für Urologie</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie</name>
      <address>
        <city>Homburg/Saar</city>
        <zip>66424</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen; Klinik für Urologie</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cork Uni Hospital; Oncology Dept</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adelaide &amp; Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit</name>
      <address>
        <city>Dublin</city>
        <zip>24</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center; Oncology Dept</name>
      <address>
        <city>Beer Sheva</city>
        <zip>8410100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus; Oncology</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Ein Karem Hospital; Oncology Dept</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center; Oncology</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belinson Medical Center, Division of Oncology</name>
      <address>
        <city>Petach Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chaim Sheba medical center, Oncology division</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5262000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center; Oncology Department</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>6423900</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica</name>
      <address>
        <city>Meldola</city>
        <state>Emilia-Romagna</state>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Universitaria Policlinico Di Modena; Oncologia</name>
      <address>
        <city>Modena</city>
        <state>Emilia-Romagna</state>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico San Matteo, Oncologia</name>
      <address>
        <city>Pavia</city>
        <state>Lombardia</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia</name>
      <address>
        <city>Arezzo</city>
        <state>Toscana</state>
        <zip>52100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima</name>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya University Hospital</name>
      <address>
        <city>Aichi</city>
        <zip>466-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hirosaki University Hospital</name>
      <address>
        <city>Aomori</city>
        <zip>036-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Hyogo</city>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tsukuba Hospital</name>
      <address>
        <city>Ibaraki</city>
        <zip>305-8576</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mie University Hospital</name>
      <address>
        <city>Mie</city>
        <zip>514-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical &amp; Dental Hospital</name>
      <address>
        <city>Niigata</city>
        <zip>951-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jichi Medical University Hospital</name>
      <address>
        <city>Tochigi</city>
        <zip>329-0498</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokushima University Hospital</name>
      <address>
        <city>Tokushima</city>
        <zip>770-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toranomon Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8470</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical and Dental University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women?s Medical University Adachi Medical Center</name>
      <address>
        <city>Tokyo</city>
        <zip>123-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital of JFCR</name>
      <address>
        <city>Tokyo</city>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VU Medisch Centrum; VU University Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1007 MB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC Radboud Nijmegen</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sint Franciscus Gasthuis; Inwendige Geneeskunde</name>
      <address>
        <city>Rotterdam</city>
        <zip>3045 PM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius locatie Leidsche Rijn</name>
      <address>
        <city>Utrecht</city>
        <zip>3543 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii</name>
      <address>
        <city>Kraków</city>
        <zip>30-688</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narodowy Inst.Onkol.im.Sk?odowskiej-Curie Pa?stw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej</name>
      <address>
        <city>Kraków</city>
        <zip>31-115</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii</name>
      <address>
        <city>Pozna?</city>
        <zip>60-569</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.</name>
      <address>
        <city>Warszawa</city>
        <zip>04-073</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-556</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altai Region Oncology Dispensory; Oncology</name>
      <address>
        <city>Barnaul</city>
        <state>Altaj</state>
        <zip>656049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P.A. Herzen Oncological Inst. ; Oncology</name>
      <address>
        <city>Moscow</city>
        <state>Moskovskaja Oblast</state>
        <zip>125248</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Oncology Hospital</name>
      <address>
        <city>Moscow</city>
        <state>Moskovskaja Oblast</state>
        <zip>143423</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privolzhsk Regional Medical Center</name>
      <address>
        <city>Nizhny Novgorod</city>
        <state>Niznij Novgorod</state>
        <zip>603001</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Oncology Dispensary</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Sankt Petersburg</state>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sverdlovsk Regional Clinical Hospital 1</name>
      <address>
        <city>Yekaterinburg</city>
        <state>Sverdlovsk</state>
        <zip>620102</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic for Urology, Clinical Center of Serbia; Clinic for Urology</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic for Urology; Military Medical Academy</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Institute of Vojvodina</name>
      <address>
        <city>Sremska Kamenica</city>
        <zip>21204</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. Central de Asturias; Servicio de Oncologia</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ Vall d'Hebron; Servicio de Oncologia</name>
      <address>
        <city>Sant Andreu de La Barca</city>
        <state>Barcelona</state>
        <zip>08740</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia; Servicio de Oncologia</name>
      <address>
        <city>Córdoba</city>
        <state>Cordoba</state>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>LA Coruña</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic i Provincial; Servicio de Oncología</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala d Oncologia Hospital Duran i Reynals</name>
      <address>
        <city>Barcelona</city>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon y Cajal; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Clínico San Carlos; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre; Servicio de Oncologia</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital; Urology</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital; Division of Urology</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital, Department of Urology</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TAIPEI VETERANS GENERAL HOSPITAL, Urology</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation-Linkou, Urinary Oncology</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Division of Urological surgery; Department of surgery, Chulalongkorn University</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit</name>
      <address>
        <city>Chiangmai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology</name>
      <address>
        <city>Adana</city>
        <zip>01230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gazi University Medical Faculty; Department of ?nternal Medicine</name>
      <address>
        <city>Ankara</city>
        <zip>06500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Uni School of Medicine; Medical Oncology</name>
      <address>
        <city>Ankara</city>
        <zip>06590</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trakya University Medical Faculty</name>
      <address>
        <city>Edirne</city>
        <zip>22030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe Uni Medical Faculty Hospital; Oncology Dept</name>
      <address>
        <city>Sihhiye/Ankara</city>
        <zip>06230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4</name>
      <address>
        <city>Kharkiv</city>
        <state>Kharkiv Governorate</state>
        <zip>61037</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR</name>
      <address>
        <city>Dnipropetrovsk</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction</name>
      <address>
        <city>Lviv</city>
        <zip>79034</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Sumy</city>
        <zip>40005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zaporizhzhia Regional Clinic</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <zip>NW3 2QS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M20 3BG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Freeman Hospital</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weston Park Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2SJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singleton Hospital; Pharmacy Department</name>
      <address>
        <city>Swansea</city>
        <zip>SA2 8QA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>China</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Uruguay</country>
  </removed_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <results_first_submitted>April 18, 2023</results_first_submitted>
  <results_first_submitted_qc>July 14, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 3, 2023</results_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 12, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03024996/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 15, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03024996/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>5 participants were randomized but did not receive any treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Atezolizumab</title>
          <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="390"/>
                <participants group_id="P2" count="388"/>
              </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="390"/>
                <participants group_id="P2" count="388"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease relapse</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study terminated by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="303"/>
                <participants group_id="P2" count="283"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Atezolizumab</title>
          <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</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="390"/>
            <count group_id="B2" value="388"/>
            <count group_id="B3" value="778"/>
          </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="59.7" spread="11.3"/>
                    <measurement group_id="B2" value="59.6" spread="10.7"/>
                    <measurement group_id="B3" value="59.7" spread="11.0"/>
                  </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="103"/>
                    <measurement group_id="B2" value="110"/>
                    <measurement group_id="B3" value="213"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="287"/>
                    <measurement group_id="B2" value="278"/>
                    <measurement group_id="B3" value="565"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="334"/>
                    <measurement group_id="B2" value="327"/>
                    <measurement group_id="B3" value="661"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="38"/>
                  </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="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="324"/>
                    <measurement group_id="B2" value="304"/>
                    <measurement group_id="B3" value="628"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Investigator-assessed Disease-Free Survival (DFS)</title>
        <description>Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.</description>
        <time_frame>From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)</time_frame>
        <population>The Intent-to-Treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator-assessed Disease-Free Survival (DFS)</title>
          <description>Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.</description>
          <population>The Intent-to-Treat (ITT) population was defined as all randomized participants regardless of whether the assigned study treatment was received.</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="390"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.2" lower_limit="44.6" upper_limit="NA">NA = small number of events to calculate the upper CI limit</measurement>
                    <measurement group_id="O2" value="49.5" lower_limit="47.4" upper_limit="NA">NA = small number of events to calculate the upper CI limit</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4950</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the time from randomization to death from any cause.</description>
        <time_frame>From baseline up to death due to any cause (up to approximately 64 months)</time_frame>
        <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the time from randomization to death from any cause.</description>
          <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</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="390"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="59.8" upper_limit="NA">NA = wasn't estimable due to small number of events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA = no events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8868</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.42</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3</title>
        <description>Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as &lt;1% and IC1/2/3 was defined as &gt;=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC.</description>
        <time_frame>From baseline until first occurrence of DFS event (up to approximately 64 months)</time_frame>
        <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3</title>
          <description>Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as &lt;1% and IC1/2/3 was defined as &gt;=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC.</description>
          <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</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="232"/>
                <count group_id="O2" value="235"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.2" lower_limit="44.6" upper_limit="NA">NA = small number of events to calculate the upper CI limit</measurement>
                    <measurement group_id="O2" value="47.9" lower_limit="38.6" upper_limit="NA">NA = small number of events to calculate the upper CI limit</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2010</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.83</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>1.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Independent Review Facility (IRF)-Assessed DFS</title>
        <description>IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first.</description>
        <time_frame>From baseline until first documented recurrence event (up to approximately 64 months)</time_frame>
        <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Independent Review Facility (IRF)-Assessed DFS</title>
          <description>IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first.</description>
          <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</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="390"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="54.1" upper_limit="NA">NA = wasn't estimable due to small number of events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="49.4" upper_limit="NA">NA = wasn't estimable due to small number of events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2811</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3</title>
        <description>IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as &lt;1% and IC1/2/3 was defined as &gt;=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay.</description>
        <time_frame>From baseline until first occurrence of DFS event (up to approximately 64 months)</time_frame>
        <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3</title>
          <description>IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as &lt;1% and IC1/2/3 was defined as &gt;=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay.</description>
          <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</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="232"/>
                <count group_id="O2" value="235"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA = no events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="41.4" upper_limit="NA">NA = wasn't estimable due to small number of events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0735</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IRF-assessed Event-free Survival (EFS)</title>
        <description>IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions.</description>
        <time_frame>From baseline until first documented recurrence event (up to approximately 64 months)</time_frame>
        <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>IRF-assessed Event-free Survival (EFS)</title>
          <description>IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions.</description>
          <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</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="390"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="54.1" upper_limit="NA">NA = wasn't estimable due to small number of events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="45.4" upper_limit="NA">NA = wasn't estimable due to small number of events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1396</p_value>
            <method>Log Rank</method>
            <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>0.67</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease-Specific Survival</title>
        <description>Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).</description>
        <time_frame>From baseline up to death due to RCC (up to approximately 64 months)</time_frame>
        <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Disease-Specific Survival</title>
          <description>Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).</description>
          <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</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="390"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA = no events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA = no events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4762</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distant Metastasis-Free Survival</title>
        <description>Distant metastasis-free survival, defined as the time from randomization to death from any cause or the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator, whichever occurred first.</description>
        <time_frame>From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)</time_frame>
        <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Distant Metastasis-Free Survival</title>
          <description>Distant metastasis-free survival, defined as the time from randomization to death from any cause or the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator, whichever occurred first.</description>
          <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</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="390"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="48.4" upper_limit="NA">NA = wasn't estimable due to small number of events</measurement>
                    <measurement group_id="O2" value="52.9" lower_limit="47.9" upper_limit="NA">NA = small number of events to calculate the upper CI limit</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5111</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3</title>
        <description>IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization.</description>
        <time_frame>Up to 3 years</time_frame>
        <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3</title>
          <description>IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization.</description>
          <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="390"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Year 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.01"/>
                    <measurement group_id="O2" value="76.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.40"/>
                    <measurement group_id="O2" value="68.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.04"/>
                    <measurement group_id="O2" value="62.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3</title>
        <description>Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization.</description>
        <time_frame>Up to 3 years</time_frame>
        <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3</title>
          <description>Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization.</description>
          <population>The ITT population was defined as all randomized participants regardless of whether the assigned study treatment was received.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="390"/>
                <count group_id="O2" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Year 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="288"/>
                    <count group_id="O2" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.41"/>
                    <measurement group_id="O2" value="74.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.32"/>
                    <measurement group_id="O2" value="65.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Year 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.43"/>
                    <measurement group_id="O2" value="59.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Adverse Events</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.</description>
        <time_frame>From baseline up to death due to any cause (up to approximately 71 months)</time_frame>
        <population>The safety population included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Adverse Events</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.</description>
          <population>The safety population included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.</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="390"/>
                <count group_id="O2" value="383"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="373"/>
                    <measurement group_id="O2" value="341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Serum Concentration (Cmax) of Atezolizumab</title>
        <time_frame>Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)</time_frame>
        <population>The pharmacokinetic (PK) population included all randomized participants who received any any dose of study treatment and who had at least one measurable post-baseline PK sample available.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Serum Concentration (Cmax) of Atezolizumab</title>
          <population>The pharmacokinetic (PK) population included all randomized participants who received any any dose of study treatment and who had at least one measurable post-baseline PK sample available.</population>
          <units>Micrograms per milliliter (ug/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="369"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="399" spread="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Serum Concentration (Cmin) of Atezolizumab</title>
        <time_frame>Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)</time_frame>
        <population>The PK population included all randomized participants who received any any dose of study treatment and who had at least one measurable post-baseline PK sample available.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Serum Concentration (Cmin) of Atezolizumab</title>
          <population>The PK population included all randomized participants who received any any dose of study treatment and who had at least one measurable post-baseline PK sample available.</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.1" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab</title>
        <time_frame>Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)</time_frame>
        <population>The immunogenicity analysis population will consist of all participants with at least one ADA assessment for atezolizumab. The post-baseline ADA evaluable population included all participants who received at least one dose of atezolizumab and with at least one post-dose ADA assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab</title>
            <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab</title>
          <population>The immunogenicity analysis population will consist of all participants with at least one ADA assessment for atezolizumab. The post-baseline ADA evaluable population included all participants who received at least one dose of atezolizumab and with at least one post-dose ADA assessment.</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="390"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Emergent ADAs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 71 months)</time_frame>
      <desc>All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants regardless of whether the assigned study treatment was received. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study treatment, regardless of whether a full or partial dose was received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Atezolizumab</title>
          <description>Participants received atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurred first).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="390"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="388"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="390"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Basedow's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness unilateral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Eosinophilic colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Immune-mediated adverse reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Systemic immune activation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Herpes ophthalmic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Mediastinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Meningitis aseptic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Pharyngeal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="390"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Salpingitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="390"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Post procedural fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="390"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Polymyositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Bladder papilloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Colorectal adenoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Gallbladder cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Axonal neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </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" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Dermatitis psoriasiform</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="390"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="390"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 25.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="329" subjects_at_risk="390"/>
                <counts group_id="E2" subjects_affected="290" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="29" subjects_affected="24" subjects_at_risk="390"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="21" subjects_affected="20" subjects_at_risk="390"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="62" subjects_affected="56" subjects_at_risk="390"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="31" subjects_affected="26" subjects_at_risk="390"/>
                <counts group_id="E2" events="24" subjects_affected="23" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="29" subjects_affected="26" subjects_at_risk="390"/>
                <counts group_id="E2" events="28" subjects_affected="26" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="128" subjects_affected="85" subjects_at_risk="390"/>
                <counts group_id="E2" events="125" subjects_affected="79" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="29" subjects_affected="26" subjects_at_risk="390"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="64" subjects_affected="46" subjects_at_risk="390"/>
                <counts group_id="E2" events="77" subjects_affected="54" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="390"/>
                <counts group_id="E2" events="29" subjects_affected="28" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="47" subjects_affected="36" subjects_at_risk="390"/>
                <counts group_id="E2" events="28" subjects_affected="26" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="145" subjects_affected="110" subjects_at_risk="390"/>
                <counts group_id="E2" events="124" subjects_affected="93" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="39" subjects_affected="29" subjects_at_risk="390"/>
                <counts group_id="E2" events="27" subjects_affected="18" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="26" subjects_affected="21" subjects_at_risk="390"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="44" subjects_affected="41" subjects_at_risk="390"/>
                <counts group_id="E2" events="32" subjects_affected="16" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="30" subjects_affected="23" subjects_at_risk="390"/>
                <counts group_id="E2" events="32" subjects_affected="26" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="39" subjects_affected="33" subjects_at_risk="390"/>
                <counts group_id="E2" events="31" subjects_affected="27" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="29" subjects_affected="26" subjects_at_risk="390"/>
                <counts group_id="E2" events="15" subjects_affected="12" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="36" subjects_affected="29" subjects_at_risk="390"/>
                <counts group_id="E2" events="39" subjects_affected="29" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="390"/>
                <counts group_id="E2" events="22" subjects_affected="21" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="26" subjects_affected="21" subjects_at_risk="390"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="101" subjects_affected="78" subjects_at_risk="390"/>
                <counts group_id="E2" events="75" subjects_affected="57" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="52" subjects_affected="43" subjects_at_risk="390"/>
                <counts group_id="E2" events="55" subjects_affected="45" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="40" subjects_affected="35" subjects_at_risk="390"/>
                <counts group_id="E2" events="39" subjects_affected="25" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="20" subjects_affected="18" subjects_at_risk="390"/>
                <counts group_id="E2" events="24" subjects_affected="20" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="30" subjects_affected="29" subjects_at_risk="390"/>
                <counts group_id="E2" events="33" subjects_affected="29" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="65" subjects_affected="51" subjects_at_risk="390"/>
                <counts group_id="E2" events="72" subjects_affected="49" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="63" subjects_affected="51" subjects_at_risk="390"/>
                <counts group_id="E2" events="51" subjects_affected="48" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="34" subjects_affected="26" subjects_at_risk="390"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="94" subjects_affected="74" subjects_at_risk="390"/>
                <counts group_id="E2" events="61" subjects_affected="48" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="55" subjects_affected="46" subjects_at_risk="390"/>
                <counts group_id="E2" events="24" subjects_affected="20" subjects_at_risk="383"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="33" subjects_affected="25" subjects_at_risk="390"/>
                <counts group_id="E2" events="17" subjects_affected="14" subjects_at_risk="383"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="20" subjects_affected="19" subjects_at_risk="390"/>
                <counts group_id="E2" events="41" subjects_affected="36" subjects_at_risk="383"/>
              </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>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800 821-8590</phone>
      <email>genentech@druginfo.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/NCT03024996
org study id: WO39210
secondary id: 2016-001881-27
nct id: NCT03024996
lead sponsor: 
has dmc: Yes
This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to
      evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who
      are at high risk of disease recurrence following nephrectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Investigator-assessed Disease-Free Survival (DFS)
time frame: From baseline up to first occurence of event by investigator assessment (up to approximately 64 months)
description: Investigator-assessed DFS, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS.
measure: Overall Survival (OS)
time frame: From baseline up to death due to any cause (up to approximately 64 months)
description: OS was defined as the time from randomization to death from any cause.
measure: Investigator-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3
time frame: From baseline until first occurrence of DFS event (up to approximately 64 months)
description: Investigator assessed DFS for participants with PD-L1 expression of IC1/2/3 vs IC0, defined as the time from randomization to death from any cause or the first documented recurrence assessed by investigator, whichever occurred first. Investigator-assessed DFS was analyzed similarly to the analysis of IRF-assessed DFS. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay. Recurrence was defined as any of the following: Local recurrence of renal cell carcinoma (RCC), new primary RCC, or distant metastasis of RCC.
measure: Independent Review Facility (IRF)-Assessed DFS
time frame: From baseline until first documented recurrence event (up to approximately 64 months)
description: IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first.
measure: IRF-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3
time frame: From baseline until first occurrence of DFS event (up to approximately 64 months)
description: IRF-assessed DFS was defined as the time from randomization to death from any cause or the first documented recurrence assessed by IRF, whichever occurred first. PD-L1 IC0 was defined as <1% and IC1/2/3 was defined as >=1% of tumor-infiltrating IC expressing PD-L1 as assessed by immunohistochemistry using SP142 assay.
measure: IRF-assessed Event-free Survival (EFS)
time frame: From baseline until first documented recurrence event (up to approximately 64 months)
description: IRF-assessed EFS was defined as the time from randomization to death from any cause, or the first documented recurrence in participants without baseline disease by IRF or the first documented disease progression in participants identified as having baseline disease by IRF, whichever occurred first. Disease progression was defined as either unequivocal progression of baseline disease or new unequivocal lesions.
measure: Disease-Specific Survival
time frame: From baseline up to death due to RCC (up to approximately 64 months)
description: Disease-specific survival was defined as the time from randomization to death from renal cell carcinoma (RCC).
measure: Distant Metastasis-Free Survival
time frame: From baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 64 months)
description: Distant metastasis-free survival, defined as the time from randomization to death from any cause or the date of diagnosis of distant (i.e., non-locoregional) metastases assessed by the investigator, whichever occurred first.
measure: Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 1, 2, and 3
time frame: Up to 3 years
description: IRF-assessed DFS was defined as the percentage of participants being alive and free of recurrence assessed by IRF at Year 1, 2, and 3 after randomization.
measure: Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 1, 2, and 3
time frame: Up to 3 years
description: Investigator-assessed DFS rate was defined as the percentage of participants being alive and free of recurrence assessed by investigator at Year 1, 2, and 3 after randomization.
measure: Percentage of Participants With Adverse Events
time frame: From baseline up to death due to any cause (up to approximately 71 months)
description: An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unitended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a pharmaceutical product whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as a AEs.
measure: Maximum Serum Concentration (Cmax) of Atezolizumab
time frame: Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
measure: Minimum Serum Concentration (Cmin) of Atezolizumab
time frame: Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
measure: Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab
time frame: Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
arm group label: Atezolizumab
arm group type: Experimental
description: Participants will receive atezolizumab 1200 milligrams (mg) intravenous (IV) infusion every 3 weeks (q3w) for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive placebo matching to atezolizumab q3w for 16 cycles (each cycle=21 days) or 1 year (whichever occurs first).
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab 1200 mg IV infusion q3w
arm group label: Atezolizumab
intervention type: Other
intervention name: Placebo
description: Placebo matching to atezolizumab q3w
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: Canada
country: Chile
country: China
country: Czechia
country: Denmark
country: France
country: Germany
country: Ireland
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: Poland
country: Russian Federation
country: Serbia
country: Spain
country: Taiwan
country: Thailand
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
country: Czech Republic
country: Uruguay
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Atezolizumab
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 