<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/NCT03016312</url>
  </required_header>
  <id_info>
    <org_study_id>CO39385</org_study_id>
    <secondary_id>2016-003092-22</secondary_id>
    <nct_id>NCT03016312</nct_id>
  </id_info>
  <brief_title>A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen</brief_title>
  <acronym>IMbassador250</acronym>
  <official_title>A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase III, multicenter, randomized, open-label study will evaluate the safety and&#xD;
      efficacy of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in&#xD;
      combination with enzalutamide compared with enzalutamide alone in participants with mCRPC&#xD;
      after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of,&#xD;
      ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of&#xD;
      the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide&#xD;
      alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants&#xD;
      will receive treatment until investigator-assessed confirmed radiographic disease progression&#xD;
      per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Actual">December 20, 2022</completion_date>
  <primary_completion_date type="Actual">December 20, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Baseline until death from any cause (up to approximately 42 months)</time_frame>
    <description>Overall Survival is defined as the time from randomization to death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Survived at Month 12 and 24</measure>
    <time_frame>Months 12, 24</time_frame>
    <description>OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 12 and 24 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Symptomatic Skeletal Event (SSE)</measure>
    <time_frame>Baseline up to end of study (up to approximately 42 months)</time_frame>
    <description>An SSE is defined as external beam radiation therapy to relieve skeletal symptoms (including initiation of radium-223 dichloride or other types of radionuclide therapy to treat symptoms of bone metastases), new symptomatic pathologic bone fracture, clinically apparent occurrence of spinal cord compression, or tumor related orthopedic surgical intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria</measure>
    <time_frame>Baseline until disease progression or death from any cause (up to approximately 42 months)</time_frame>
    <description>rPFS is defined as the time from randomization to the earliest occurrence of one of the following:&#xD;
A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed &lt; 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.&#xD;
Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1&#xD;
Death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria</measure>
    <time_frame>Months 6, 12</time_frame>
    <description>rPFS is defined as the time from randomization to the earliest occurrence of one of the following:&#xD;
A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed &lt; 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.&#xD;
Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1&#xD;
Death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Greater Than (&gt;) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline</measure>
    <time_frame>Baseline until disease progression (up to approximately 42 months)</time_frame>
    <description>PSA response rate, defined as a &gt; 50% decrease in PSA from baseline that is confirmed after ≥ 3 weeks by a consecutive confirmatory PSA measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to PSA Progression, Assessed as Per PCWG3 Criteria</measure>
    <time_frame>Baseline until disease progression (up to approximately 42 months)</time_frame>
    <description>In participants with no PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the baseline value, ≥12 weeks after baseline. In participants with an initial PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥3 weeks later.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria</measure>
    <time_frame>Baseline until disease progression or death from any cause (up to approximately 42 months)</time_frame>
    <description>Objective response rate in soft tissue lesions, defined as the percentage of participants with either a CR or PR on two consecutive occasions ≥ 6 weeks apart, as determined by the investigator through use of PCWG3 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events</measure>
    <time_frame>Baseline up to end of study (up to approximately 42 month</time_frame>
    <description>Verbatim description of adverse events will be coded to MedDRA preferred terms and graded according to NCI CTCAE v4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Observed Serum Concentration (Cmin) of Atezolizumab</measure>
    <time_frame>Pre-infusion (0 hour[hr]) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)</time_frame>
    <description>Atezolizumab serum concentration data (minimum [Cmin]) will be reported and summarized for each cycle where collected as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) of Atezolizumab</measure>
    <time_frame>Pre-infusion (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); 0.5 hr post-infusion (infusion duration: 60 minutes [min]) on Day 1 Cycle 1; treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)</time_frame>
    <description>Atezolizumab serum concentration data (maximum [Cmax]) will be reported and summarized for each cycle where collected as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of Enzalutamide</measure>
    <time_frame>Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8</time_frame>
    <description>Plasma concentrations of Enzalutamide will be reported and summarized using descriptive statistics for each cycle and treatment arm, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of N-Desmethyl Enzalutamide</measure>
    <time_frame>Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8</time_frame>
    <description>Plasma concentrations of N-desmethyl enzalutamide will be reported and summarized using descriptive statistics for each cycle and treatment arm, as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab</measure>
    <time_frame>Predose (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); at atezolizumab discontinuation visit (30 days after last dose); 120 days after last dose of atezolizumab; up to 42 months</time_frame>
    <description>The numbers and proportions of ATA-positive participants and ATA-negative participants at baseline (baseline prevalence) and after baseline (post-baseline incidence) will be summarized by treatment group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">772</enrollment>
  <condition>Prostatic Neoplasms, Castration-Resistant</condition>
  <arm_group>
    <arm_group_label>Atezolizumab + Enzalutamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enzalutamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle.</description>
    <arm_group_label>Atezolizumab + Enzalutamide</arm_group_label>
    <other_name>Tecentriq®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <description>Enzalutamide capsules will be administered orally at a dose of 160 mg daily.</description>
    <arm_group_label>Atezolizumab + Enzalutamide</arm_group_label>
    <arm_group_label>Enzalutamide</arm_group_label>
    <other_name>Xtandi®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Life expectancy greater than or equal to (&gt;/=) 3 months&#xD;
&#xD;
          -  Histologically confirmed adenocarcinoma of the prostate&#xD;
&#xD;
          -  Known castrate-resistant disease with serum testosterone level less than or equal to&#xD;
             (&lt;/=) 50 nanograms per deciliter (ng/dL) with prior surgical castration or ongoing&#xD;
             androgen deprivation for the duration of the study&#xD;
&#xD;
          -  Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or&#xD;
             following the direct prior line of therapy in the setting of medical or surgical&#xD;
             castration&#xD;
&#xD;
          -  One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or&#xD;
             ineligibility of a taxane-containing regimen&#xD;
&#xD;
          -  Progression on a prior regimen/line of an androgen synthesis inhibitor for prostate&#xD;
             cancer&#xD;
&#xD;
          -  Availability of a representative tumor specimen from a site not previously irradiated&#xD;
             that is suitable for determination of programmed death-ligand 1 (PD-L1) status via&#xD;
             central testing&#xD;
&#xD;
          -  Adequate hematologic and end organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with enzalutamide or any other newer hormonal androgen receptor&#xD;
             inhibitor (e.g., apalutamide, ODM-201)&#xD;
&#xD;
          -  Treatment with any approved anti-cancer therapy, including chemotherapy,&#xD;
             immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of&#xD;
             abiraterone), within 4 weeks prior to initiation of study treatment&#xD;
&#xD;
          -  Treatment with abiraterone within 2 weeks prior to study treatment&#xD;
&#xD;
          -  Structurally unstable bone lesions suggesting impending fracture&#xD;
&#xD;
          -  Known or suspected brain metastasis or active leptomeningeal disease&#xD;
&#xD;
          -  Major surgical procedure other than for diagnosis within 4 weeks prior to initiation&#xD;
             of study treatment or anticipation of need for a major surgical procedure during the&#xD;
             course of the study&#xD;
&#xD;
          -  Active or history of autoimmune disease or immune deficiency&#xD;
&#xD;
          -  Prior allogeneic stem cell or solid organ transplantation&#xD;
&#xD;
          -  History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis&#xD;
             obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of&#xD;
             active pneumonitis on screening chest computed tomography (CT) scan&#xD;
&#xD;
          -  Positive human immunodeficiency virus (HIV) test, active tuberculosis, active&#xD;
             hepatitis B virus (HBV) or hepatitis C virus (HCV) infection&#xD;
&#xD;
          -  Prior treatment with cluster of differentiation (CD)137 agonists or immune checkpoint&#xD;
             blockade therapies, including anti Cytotoxic T Lymphocyte-Associated 4 (CTLA4),&#xD;
             anti-programmed death 1 (PD-1), and anti-PD-L1 therapeutic antibodies&#xD;
&#xD;
          -  Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of&#xD;
             the drug, whichever is shorter, prior to initiation of study treatment&#xD;
&#xD;
          -  Treatment with systemic immunosuppressive medication within 2 weeks prior to&#xD;
             initiation of study&#xD;
&#xD;
          -  History of seizure or any condition that may predispose to seizure within 12 months&#xD;
             prior to study treatment, including history of unexplained loss of consciousness or&#xD;
             transient ischemic attack&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>City of Hope Medical Grp Inc.</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente San Diego - Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Irvine Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Hematology Oncology Associates</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado; Division of Medical Oncology</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80021</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>Stamford Hospital; BCC, MOHR</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Cancer Institute/Boca Raton Regional Hospital</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI Florida Cancer Specialists South</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute of Baptist Health, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialist, North Region</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Clin Rsch of IN</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associates in Oncology/Hematology P.C.</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute..</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Cancer Specialists; Oncology Hematology West, PC</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Cancer Center &amp; GU Research Network</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MSKCC at Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Oncology Hematology, P.C.</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology Care, Inc.</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Cancer Hospital;Solove Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Cancer Institute; Division of Medical Oncology</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Oncology, P .A</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Urologic Research Center</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI Tennessee Oncology Chattanooga</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology Cancer Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Methodist Dallas Cancer Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A. - Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Memorial City</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Tyler</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists - Alexandria</name>
      <address>
        <city>Alexandria</city>
        <state>Virginia</state>
        <zip>22304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Health; Cancer Services</name>
      <address>
        <city>Box Hill</city>
        <state>New South Wales</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Concord Repatriation General Hospital; Concord Cancer Centre</name>
      <address>
        <city>Concord</city>
        <state>New South Wales</state>
        <zip>2139</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macquarie University Hospital</name>
      <address>
        <city>Macquarie Park</city>
        <state>New South Wales</state>
        <zip>2109</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>Adelaide Cancer Centre</name>
      <address>
        <city>Kurralta Park</city>
        <state>South Australia</state>
        <zip>5037</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre; Oncology</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</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>Medizinische Universität Wien; Universitätsklinik für Urologie</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouwziekenhuis Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sart-Tilman</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</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>Kingston General Hospital</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeridge Health Oshawa; Oncology</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</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>Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2H1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</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>CHU de Québec - Université Laval - Hôtel-Dieu de Québec</name>
      <address>
        <city>Quebec</city>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <zip>100050</zip>
        <country>China</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</name>
      <address>
        <city>Shanghai City</city>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</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 u sv. Anny v Brne</name>
      <address>
        <city>Brno</city>
        <zip>656 91</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>Aalborg Universitetshospital; Klinik Kirurgi-Kræft, Onkologisk afd.</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</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>Odense Universitetshospital, Onkologisk Afdeling R</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Sainte-Catherine; Oncologie</name>
      <address>
        <city>Avignon</city>
        <zip>84082</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Francois Baclesse; Oncologie</name>
      <address>
        <city>Caen</city>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Louis Pasteur; Medecine B</name>
      <address>
        <city>Colmar</city>
        <zip>68024</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret; Chir Cancerologie General</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Chenieux; Oncology</name>
      <address>
        <city>Limoges</city>
        <zip>87039</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Louis, Service D Oncologie Medicale</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital d'Instruction des Armees de Begin</name>
      <address>
        <city>Saint-Mande</city>
        <zip>94160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud; Departement Oncologie Medicale</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</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 Freiburg; Chirurgische Klinik; Abteilung Urologie</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie</name>
      <address>
        <city>Münster</city>
        <zip>48149</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>Urologisches Zentrum Euregio; Würselen, Urologische Praxis am Wasserturm</name>
      <address>
        <city>Würselen</city>
        <zip>52146</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine</name>
      <address>
        <city>Athens</city>
        <zip>115 22</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine</name>
      <address>
        <city>Athens</city>
        <zip>115 28</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Athens Medical Center; Dept. of Oncology</name>
      <address>
        <city>Athens</city>
        <zip>151 25</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IASO General Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <zip>155 62</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.</name>
      <address>
        <city>Kifisia</city>
        <zip>145 64</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Patras Medical Oncology</name>
      <address>
        <city>Patras</city>
        <zip>265 04</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Papageorgiou General Hospital; Medical Oncology</name>
      <address>
        <city>Thessaloniki</city>
        <zip>564 29</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelwies University of Medicine; Urology Dept.</name>
      <address>
        <city>Budapest</city>
        <zip>1082</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orszagos Onkologiai Intezet; &quot;C&quot; Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont ; Department of Oncology</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</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>Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00152</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS AOU San Martino - IST; Oncologia Medica 1</name>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia</name>
      <address>
        <city>Cremona</city>
        <state>Lombardia</state>
        <zip>26100</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>Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica</name>
      <address>
        <city>Bari</city>
        <state>Puglia</state>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>Puglia</state>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Area Aretina Nord; 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 City University Hospital</name>
      <address>
        <city>Aichi</city>
        <zip>467-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center East</name>
      <address>
        <city>Chiba</city>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Sakura Medical Center</name>
      <address>
        <city>Chiba</city>
        <zip>285-8741</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>National Hospital Organization Hokkaido Cancer Center</name>
      <address>
        <city>Hokkaido</city>
        <zip>003-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Medical Center</name>
      <address>
        <city>Kanagawa</city>
        <zip>232-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kitasato University Hospital</name>
      <address>
        <city>Kanagawa</city>
        <zip>252-0375</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Kyoto Prefectural University of Medicine</name>
      <address>
        <city>Kyoto</city>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nara Medical University Hospital</name>
      <address>
        <city>Nara</city>
        <zip>634-8522</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>Kansai Medical University Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>573-1191</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>The Jikei University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8471</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>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</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>Medical University of Bialystok; Oncology clinic</name>
      <address>
        <city>Bialystok</city>
        <zip>15-027</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Przychodnia Lekarska KOMED, Roman Karaszewski</name>
      <address>
        <city>Konin</city>
        <zip>62-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii</name>
      <address>
        <city>Kraków</city>
        <zip>30-688</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego</name>
      <address>
        <city>Opole</city>
        <zip>45-060</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii</name>
      <address>
        <city>Otwock</city>
        <zip>05-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.</name>
      <address>
        <city>Warszawa</city>
        <zip>02-616</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital; Specjalistyczny ul.</name>
      <address>
        <city>Wroclaw</city>
        <zip>51-124</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woj. Wielospec. Centrum Onkologii i Traumatologii</name>
      <address>
        <city>Łódź</city>
        <zip>93-513</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBEI HPE &quot;The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova&quot;of MoH of RF</name>
      <address>
        <city>Sankt-peterburg</city>
        <state>Leningrad</state>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Scientific Center of Roentgenoradiology</name>
      <address>
        <city>Moscow</city>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P.A. Herzen Oncological Inst. ; Oncology</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala d´Oncologia Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Insititut Catala D'Oncologia</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporacio Sanitaria Parc Tauli; Servicio de Oncologia</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>8208</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>Clinica Universitaria de Navarra; Servicio de Oncologia</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron; Oncology</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</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>Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</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 Clinico 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>Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio; Servicio de Oncologia</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern; Universitätsklinik für medizinische Onkologie</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen; Onkologie/Hämatologie</name>
      <address>
        <city>St. Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</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 Memorial Hospital-LinKou; Urology</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Blackburn Hospital</name>
      <address>
        <city>Blackburn</city>
        <zip>BB2 3HH</zip>
        <country>United Kingdom</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>Barts and the London NHS Trust.</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>London</city>
        <zip>W1G 6AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital; Institute of Cancer Research</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>China</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <results_first_submitted>April 5, 2021</results_first_submitted>
  <results_first_submitted_qc>April 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 30, 2021</results_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 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>Prostatic Neoplasms</mesh_term>
    <mesh_term>Prostatic Neoplasms, Castration-Resistant</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 and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03016312/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Atezolizumab + Enzalutamide</title>
          <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
        </group>
        <group group_id="P2">
          <title>Enzalutamide</title>
          <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="391"/>
                <participants group_id="P2" count="380"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="150"/>
                <participants group_id="P2" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="241"/>
                <participants group_id="P2" count="218"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="194"/>
                <participants group_id="P2" count="164"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Started new therapy, loss of contact</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Atezolizumab + Enzalutamide</title>
          <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
        </group>
        <group group_id="B2">
          <title>Enzalutamide</title>
          <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</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="391"/>
            <count group_id="B2" value="380"/>
            <count group_id="B3" value="771"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="191"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="290"/>
                    <measurement group_id="B2" value="290"/>
                    <measurement group_id="B3" value="580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="70.3" spread="8.3"/>
                    <measurement group_id="B2" value="70.6" spread="8.5"/>
                    <measurement group_id="B3" value="70.4" spread="8.4"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="391"/>
                    <measurement group_id="B2" value="380"/>
                    <measurement group_id="B3" value="771"/>
                  </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="18"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="349"/>
                    <measurement group_id="B2" value="345"/>
                    <measurement group_id="B3" value="694"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="290"/>
                    <measurement group_id="B2" value="287"/>
                    <measurement group_id="B3" value="577"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall Survival is defined as the time from randomization to death from any cause.</description>
        <time_frame>Baseline until death from any cause (up to approximately 42 months)</time_frame>
        <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab + Enzalutamide</title>
            <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
          <group group_id="O2">
            <title>Enzalutamide</title>
            <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall Survival is defined as the time from randomization to death from any cause.</description>
          <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</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="379"/>
                <count group_id="O2" value="380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" lower_limit="14.0" upper_limit="17.0"/>
                    <measurement group_id="O2" value="16.6" lower_limit="14.7" upper_limit="18.4"/>
                  </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>
            <groups_desc>Unstratified Analysis</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0940</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.184</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.971</ci_lower_limit>
            <ci_upper_limit>1.445</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stratified Analysis</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2786</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.118</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.913</ci_lower_limit>
            <ci_upper_limit>1.370</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Survived at Month 12 and 24</title>
        <description>OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 12 and 24 months</description>
        <time_frame>Months 12, 24</time_frame>
        <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab + Enzalutamide</title>
            <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
          <group group_id="O2">
            <title>Enzalutamide</title>
            <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Survived at Month 12 and 24</title>
          <description>OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 12 and 24 months</description>
          <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="379"/>
                <count group_id="O2" value="380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.12" lower_limit="81.45" upper_limit="88.78"/>
                    <measurement group_id="O2" value="85.32" lower_limit="81.67" upper_limit="88.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.61" lower_limit="55.52" upper_limit="65.71"/>
                    <measurement group_id="O2" value="64.65" lower_limit="59.60" upper_limit="69.70"/>
                  </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>
            <groups_desc>Difference in Event Free Rate - 6 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9391</p_value>
            <method>z-test</method>
            <param_type>Difference in Event Free Rate</param_type>
            <param_value>-0.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.38</ci_lower_limit>
            <ci_upper_limit>4.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in Event Free Rate - 12 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2706</p_value>
            <method>z-test</method>
            <param_type>Difference in Event Free Rate</param_type>
            <param_value>-4.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.21</ci_lower_limit>
            <ci_upper_limit>3.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Symptomatic Skeletal Event (SSE)</title>
        <description>An SSE is defined as external beam radiation therapy to relieve skeletal symptoms (including initiation of radium-223 dichloride or other types of radionuclide therapy to treat symptoms of bone metastases), new symptomatic pathologic bone fracture, clinically apparent occurrence of spinal cord compression, or tumor related orthopedic surgical intervention.</description>
        <time_frame>Baseline up to end of study (up to approximately 42 months)</time_frame>
        <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab + Enzalutamide</title>
            <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
          <group group_id="O2">
            <title>Enzalutamide</title>
            <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Symptomatic Skeletal Event (SSE)</title>
          <description>An SSE is defined as external beam radiation therapy to relieve skeletal symptoms (including initiation of radium-223 dichloride or other types of radionuclide therapy to treat symptoms of bone metastases), new symptomatic pathologic bone fracture, clinically apparent occurrence of spinal cord compression, or tumor related orthopedic surgical intervention.</description>
          <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</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="379"/>
                <count group_id="O2" value="380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.1" lower_limit="24.1" upper_limit="NA">Due to censoring, the upper limit was not estimable.</measurement>
                    <measurement group_id="O2" value="24.9" lower_limit="24.9" upper_limit="NA">Due to censoring, the upper limit was not estimable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria</title>
        <description>rPFS is defined as the time from randomization to the earliest occurrence of one of the following:&#xD;
A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed &lt; 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.&#xD;
Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1&#xD;
Death from any cause</description>
        <time_frame>Baseline until disease progression or death from any cause (up to approximately 42 months)</time_frame>
        <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab + Enzalutamide</title>
            <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
          <group group_id="O2">
            <title>Enzalutamide</title>
            <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria</title>
          <description>rPFS is defined as the time from randomization to the earliest occurrence of one of the following:&#xD;
A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed &lt; 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.&#xD;
Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1&#xD;
Death from any cause</description>
          <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</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="379"/>
                <count group_id="O2" value="380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" lower_limit="4.1" upper_limit="5.3"/>
                    <measurement group_id="O2" value="4.1" lower_limit="3.7" upper_limit="4.5"/>
                  </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>
            <groups_desc>Unstratified Analysis</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3157</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.917</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.775</ci_lower_limit>
            <ci_upper_limit>1.086</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stratified Analysis</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2366</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.899</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.754</ci_lower_limit>
            <ci_upper_limit>1.072</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria</title>
        <description>rPFS is defined as the time from randomization to the earliest occurrence of one of the following:&#xD;
A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed &lt; 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.&#xD;
Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1&#xD;
Death from any cause</description>
        <time_frame>Months 6, 12</time_frame>
        <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab + Enzalutamide</title>
            <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
          <group group_id="O2">
            <title>Enzalutamide</title>
            <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria</title>
          <description>rPFS is defined as the time from randomization to the earliest occurrence of one of the following:&#xD;
A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed &lt; 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.&#xD;
Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1&#xD;
Death from any cause</description>
          <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="379"/>
                <count group_id="O2" value="380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.84" lower_limit="36.09" upper_limit="47.60"/>
                    <measurement group_id="O2" value="39.64" lower_limit="33.86" upper_limit="45.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.89" lower_limit="10.74" upper_limit="19.05"/>
                    <measurement group_id="O2" value="13.45" lower_limit="9.42" upper_limit="17.49"/>
                  </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>
            <groups_desc>Difference in Event Free Rate - 6 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5959</p_value>
            <method>z-test</method>
            <param_type>Difference in Event Free Rate</param_type>
            <param_value>2.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.95</ci_lower_limit>
            <ci_upper_limit>10.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in Event Free Rate - 12 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6262</p_value>
            <method>z-test</method>
            <param_type>Difference in Event Free Rate</param_type>
            <param_value>1.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.35</ci_lower_limit>
            <ci_upper_limit>7.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Greater Than (&gt;) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline</title>
        <description>PSA response rate, defined as a &gt; 50% decrease in PSA from baseline that is confirmed after ≥ 3 weeks by a consecutive confirmatory PSA measurement</description>
        <time_frame>Baseline until disease progression (up to approximately 42 months)</time_frame>
        <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab + Enzalutamide</title>
            <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
          <group group_id="O2">
            <title>Enzalutamide</title>
            <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Greater Than (&gt;) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline</title>
          <description>PSA response rate, defined as a &gt; 50% decrease in PSA from baseline that is confirmed after ≥ 3 weeks by a consecutive confirmatory PSA measurement</description>
          <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants from whom data was collected and analyzed.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="379"/>
                <count group_id="O2" value="380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" lower_limit="21.5" upper_limit="30.5"/>
                    <measurement group_id="O2" value="24.2" lower_limit="20.0" upper_limit="28.7"/>
                  </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>
            <param_type>Difference in 50% Decrease Response Rate</param_type>
            <param_value>1.6</param_value>
            <ci_percent>2</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5</ci_lower_limit>
            <ci_upper_limit>7.8</ci_upper_limit>
            <other_analysis_desc>Odds Ratio: 1.1 95%CI: 0.8, 1.5</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to PSA Progression, Assessed as Per PCWG3 Criteria</title>
        <description>In participants with no PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the baseline value, ≥12 weeks after baseline. In participants with an initial PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥3 weeks later.</description>
        <time_frame>Baseline until disease progression (up to approximately 42 months)</time_frame>
        <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants in the ITT population with measurable soft tissue lesions at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab + Enzalutamide</title>
            <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
          <group group_id="O2">
            <title>Enzalutamide</title>
            <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to PSA Progression, Assessed as Per PCWG3 Criteria</title>
          <description>In participants with no PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the baseline value, ≥12 weeks after baseline. In participants with an initial PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥3 weeks later.</description>
          <population>The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, &quot;Number Analyzed&quot; refers to number of participants in the ITT population with measurable soft tissue lesions at baseline.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="379"/>
                <count group_id="O2" value="380"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="2.8" upper_limit="2.9"/>
                    <measurement group_id="O2" value="2.8" lower_limit="2.8" upper_limit="2.9"/>
                  </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>
            <groups_desc>Unstratified Analysis</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5359</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.055</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.890</ci_lower_limit>
            <ci_upper_limit>1.251</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Stratified Analysis</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6857</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.037</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.869</ci_lower_limit>
            <ci_upper_limit>1.238</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria</title>
        <description>Objective response rate in soft tissue lesions, defined as the percentage of participants with either a CR or PR on two consecutive occasions ≥ 6 weeks apart, as determined by the investigator through use of PCWG3 criteria</description>
        <time_frame>Baseline until disease progression or death from any cause (up to approximately 42 months)</time_frame>
        <population>Participants were classified as missing or unevaluable if no post-baseline response assessments were available or all post-baseline response baseline assessments were unevaluable.&#xD;
Responders had to have a CR or PR on two consecutive occasions at least 6 weeks apart.</population>
        <group_list>
          <group group_id="O1">
            <title>Atezolizumab + Enzalutamide</title>
            <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
          <group group_id="O2">
            <title>Enzalutamide</title>
            <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria</title>
          <description>Objective response rate in soft tissue lesions, defined as the percentage of participants with either a CR or PR on two consecutive occasions ≥ 6 weeks apart, as determined by the investigator through use of PCWG3 criteria</description>
          <population>Participants were classified as missing or unevaluable if no post-baseline response assessments were available or all post-baseline response baseline assessments were unevaluable.&#xD;
Responders had to have a CR or PR on two consecutive occasions at least 6 weeks apart.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7" lower_limit="8.4" upper_limit="20.7"/>
                    <measurement group_id="O2" value="7.4" lower_limit="3.7" upper_limit="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Adverse Events</title>
        <description>Verbatim description of adverse events will be coded to MedDRA preferred terms and graded according to NCI CTCAE v4.0.</description>
        <time_frame>Baseline up to end of study (up to approximately 42 month</time_frame>
        <posting_date>10/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Observed Serum Concentration (Cmin) of Atezolizumab</title>
        <description>Atezolizumab serum concentration data (minimum [Cmin]) will be reported and summarized for each cycle where collected as appropriate.</description>
        <time_frame>Pre-infusion (0 hour[hr]) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)</time_frame>
        <posting_date>10/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Serum Concentration (Cmax) of Atezolizumab</title>
        <description>Atezolizumab serum concentration data (maximum [Cmax]) will be reported and summarized for each cycle where collected as appropriate.</description>
        <time_frame>Pre-infusion (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); 0.5 hr post-infusion (infusion duration: 60 minutes [min]) on Day 1 Cycle 1; treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)</time_frame>
        <posting_date>10/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of Enzalutamide</title>
        <description>Plasma concentrations of Enzalutamide will be reported and summarized using descriptive statistics for each cycle and treatment arm, as appropriate.</description>
        <time_frame>Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8</time_frame>
        <posting_date>10/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of N-Desmethyl Enzalutamide</title>
        <description>Plasma concentrations of N-desmethyl enzalutamide will be reported and summarized using descriptive statistics for each cycle and treatment arm, as appropriate.</description>
        <time_frame>Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8</time_frame>
        <posting_date>10/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab</title>
        <description>The numbers and proportions of ATA-positive participants and ATA-negative participants at baseline (baseline prevalence) and after baseline (post-baseline incidence) will be summarized by treatment group.</description>
        <time_frame>Predose (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); at atezolizumab discontinuation visit (30 days after last dose); 120 days after last dose of atezolizumab; up to 42 months</time_frame>
        <posting_date>10/2023</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to primary completion date (up to 2 years 2 months, cut off date: June-24-2019)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Atezolizumab + Enzalutamide</title>
          <description>Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
        </group>
        <group group_id="E2">
          <title>Enzalutamide</title>
          <description>Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="216" subjects_at_risk="386"/>
                <counts group_id="E2" subjects_affected="180" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="140" subjects_at_risk="386"/>
                <counts group_id="E2" subjects_affected="83" subjects_at_risk="376"/>
              </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="11" subjects_affected="9" subjects_at_risk="386"/>
                <counts group_id="E2" events="15" subjects_affected="11" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Heparin-induced thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Autoimmune myocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="386"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness unilateral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </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="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Gastroduodenal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="386"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Complication of device insertion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="386"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Ill-defined disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="386"/>
                <counts group_id="E2" events="7" subjects_affected="2" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Infected cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Nosocomial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="386"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pneumonia legionella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="386"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Spinal cord infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Superinfection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Jaw fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </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="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </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="3" subjects_affected="3" subjects_at_risk="386"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </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="4" subjects_affected="4" subjects_at_risk="386"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="386"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="386"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Haemarthrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Torticollis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Tumour rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Cranial nerve palsies multiple</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>IIIrd nerve paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Myasthenic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </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="5" subjects_affected="5" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="13" subjects_affected="7" subjects_at_risk="386"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hydrothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hypercapnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Stevens-Johnson syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Bladder neoplasm surgery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pelvic venous thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="386"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.05</frequency_threshold>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="348" subjects_at_risk="386"/>
                <counts group_id="E2" subjects_affected="304" subjects_at_risk="376"/>
              </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="96" subjects_affected="82" subjects_at_risk="386"/>
                <counts group_id="E2" events="58" subjects_affected="49" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="24" subjects_affected="23" subjects_at_risk="386"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="90" subjects_affected="80" subjects_at_risk="386"/>
                <counts group_id="E2" events="62" subjects_affected="61" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="111" subjects_affected="89" subjects_at_risk="386"/>
                <counts group_id="E2" events="51" subjects_affected="41" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="113" subjects_affected="93" subjects_at_risk="386"/>
                <counts group_id="E2" events="72" subjects_affected="65" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="43" subjects_affected="35" subjects_at_risk="386"/>
                <counts group_id="E2" events="35" subjects_affected="32" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="97" subjects_affected="81" subjects_at_risk="386"/>
                <counts group_id="E2" events="67" subjects_affected="62" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="152" subjects_affected="134" subjects_at_risk="386"/>
                <counts group_id="E2" events="115" subjects_affected="102" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="40" subjects_affected="34" subjects_at_risk="386"/>
                <counts group_id="E2" events="30" subjects_affected="27" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="25" subjects_affected="23" subjects_at_risk="386"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="41" subjects_affected="34" subjects_at_risk="386"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="386"/>
                <counts group_id="E2" events="23" subjects_affected="20" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="24" subjects_affected="21" subjects_at_risk="386"/>
                <counts group_id="E2" events="21" subjects_affected="18" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="57" subjects_affected="54" subjects_at_risk="386"/>
                <counts group_id="E2" events="32" subjects_affected="31" subjects_at_risk="376"/>
              </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="131" subjects_affected="117" subjects_at_risk="386"/>
                <counts group_id="E2" events="113" subjects_affected="98" subjects_at_risk="376"/>
              </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="86" subjects_affected="70" subjects_at_risk="386"/>
                <counts group_id="E2" events="62" subjects_affected="46" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="100" subjects_affected="82" subjects_at_risk="386"/>
                <counts group_id="E2" events="62" subjects_affected="54" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="31" subjects_affected="27" subjects_at_risk="386"/>
                <counts group_id="E2" events="38" subjects_affected="34" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="25" subjects_affected="21" subjects_at_risk="386"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="35" subjects_affected="30" subjects_at_risk="386"/>
                <counts group_id="E2" events="35" subjects_affected="30" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="29" subjects_affected="26" subjects_at_risk="386"/>
                <counts group_id="E2" events="43" subjects_affected="37" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="31" subjects_affected="26" subjects_at_risk="386"/>
                <counts group_id="E2" events="26" subjects_affected="20" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="37" subjects_affected="34" subjects_at_risk="386"/>
                <counts group_id="E2" events="21" subjects_affected="19" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="30" subjects_affected="30" subjects_at_risk="386"/>
                <counts group_id="E2" events="29" subjects_affected="28" subjects_at_risk="376"/>
              </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="25" subjects_affected="24" subjects_at_risk="386"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="25" subjects_affected="23" subjects_at_risk="386"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="376"/>
              </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="43" subjects_affected="36" subjects_at_risk="386"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="62" subjects_affected="54" subjects_at_risk="386"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="24" subjects_affected="21" subjects_at_risk="386"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="376"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="386"/>
                <counts group_id="E2" events="22" subjects_affected="21" subjects_at_risk="376"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="33" subjects_affected="27" subjects_at_risk="386"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="376"/>
              </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/NCT03016312
org study id: CO39385
secondary id: 2016-003092-22
nct id: NCT03016312
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This Phase III, multicenter, randomized, open-label study will evaluate the safety and
      efficacy of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in
      combination with enzalutamide compared with enzalutamide alone in participants with mCRPC
      after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of,
      ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of
      the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide
      alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants
      will receive treatment until investigator-assessed confirmed radiographic disease progression
      per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS)
time frame: Baseline until death from any cause (up to approximately 42 months)
description: Overall Survival is defined as the time from randomization to death from any cause.
measure: Percentage of Participants Who Survived at Month 12 and 24
time frame: Months 12, 24
description: OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 12 and 24 months
measure: Time to First Symptomatic Skeletal Event (SSE)
time frame: Baseline up to end of study (up to approximately 42 months)
description: An SSE is defined as external beam radiation therapy to relieve skeletal symptoms (including initiation of radium-223 dichloride or other types of radionuclide therapy to treat symptoms of bone metastases), new symptomatic pathologic bone fracture, clinically apparent occurrence of spinal cord compression, or tumor related orthopedic surgical intervention.
measure: Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria
time frame: Baseline until disease progression or death from any cause (up to approximately 42 months)
description: rPFS is defined as the time from randomization to the earliest occurrence of one of the following:
A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed < 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.
Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1
Death from any cause
measure: Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria
time frame: Months 6, 12
description: rPFS is defined as the time from randomization to the earliest occurrence of one of the following:
A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed < 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.
Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1
Death from any cause
measure: Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline
time frame: Baseline until disease progression (up to approximately 42 months)
description: PSA response rate, defined as a > 50% decrease in PSA from baseline that is confirmed after ≥ 3 weeks by a consecutive confirmatory PSA measurement
measure: Time to PSA Progression, Assessed as Per PCWG3 Criteria
time frame: Baseline until disease progression (up to approximately 42 months)
description: In participants with no PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the baseline value, ≥12 weeks after baseline. In participants with an initial PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥3 weeks later.
measure: Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria
time frame: Baseline until disease progression or death from any cause (up to approximately 42 months)
description: Objective response rate in soft tissue lesions, defined as the percentage of participants with either a CR or PR on two consecutive occasions ≥ 6 weeks apart, as determined by the investigator through use of PCWG3 criteria
measure: Percentage of Participants With Adverse Events
time frame: Baseline up to end of study (up to approximately 42 month
description: Verbatim description of adverse events will be coded to MedDRA preferred terms and graded according to NCI CTCAE v4.0.
measure: Minimum Observed Serum Concentration (Cmin) of Atezolizumab
time frame: Pre-infusion (0 hour[hr]) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)
description: Atezolizumab serum concentration data (minimum [Cmin]) will be reported and summarized for each cycle where collected as appropriate.
measure: Maximum Observed Serum Concentration (Cmax) of Atezolizumab
time frame: Pre-infusion (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); 0.5 hr post-infusion (infusion duration: 60 minutes [min]) on Day 1 Cycle 1; treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)
description: Atezolizumab serum concentration data (maximum [Cmax]) will be reported and summarized for each cycle where collected as appropriate.
measure: Plasma Concentration of Enzalutamide
time frame: Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8
description: Plasma concentrations of Enzalutamide will be reported and summarized using descriptive statistics for each cycle and treatment arm, as appropriate.
measure: Plasma Concentration of N-Desmethyl Enzalutamide
time frame: Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8
description: Plasma concentrations of N-desmethyl enzalutamide will be reported and summarized using descriptive statistics for each cycle and treatment arm, as appropriate.
measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
time frame: Predose (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); at atezolizumab discontinuation visit (30 days after last dose); 120 days after last dose of atezolizumab; up to 42 months
description: The numbers and proportions of ATA-positive participants and ATA-negative participants at baseline (baseline prevalence) and after baseline (post-baseline incidence) will be summarized by treatment group.
arm group label: Atezolizumab + Enzalutamide
arm group type: Experimental
description: Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
arm group label: Enzalutamide
arm group type: Active Comparator
description: Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle.
arm group label: Atezolizumab + Enzalutamide
other name: Tecentriq®
intervention type: Drug
intervention name: Enzalutamide
description: Enzalutamide capsules will be administered orally at a dose of 160 mg daily.
arm group label: Atezolizumab + Enzalutamide
arm group label: Enzalutamide
other name: Xtandi®
criteria: 
gender: Male
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: Australia
country: Austria
country: Belgium
country: Canada
country: China
country: Czechia
country: Denmark
country: France
country: Germany
country: Greece
country: Hungary
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Spain
country: Switzerland
country: Taiwan
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prostatic Neoplasms, Castration-Resistant
mesh term: Atezolizumab
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 