<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/NCT03834519</url>
  </required_header>
  <id_info>
    <org_study_id>7339-010</org_study_id>
    <secondary_id>MK-7339-010</secondary_id>
    <secondary_id>KEYLYNK-010</secondary_id>
    <secondary_id>2018-004118-16</secondary_id>
    <nct_id>NCT03834519</nct_id>
  </id_info>
  <brief_title>Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)</brief_title>
  <acronym>KEYLYNK-010</acronym>
  <official_title>A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of the combination of the&#xD;
      polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and&#xD;
      pembrolizumab in the treatment of participants with mCRPC who have failed to respond to&#xD;
      either abiraterone acetate or enzalutamide (but not both) and to chemotherapy.&#xD;
&#xD;
      The primary study hypotheses are that the combination of pembrolizumab plus olaparib is&#xD;
      superior to abiraterone acetate or enzalutamide with respect to:&#xD;
&#xD;
        1. Overall Survival (OS) and&#xD;
&#xD;
        2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group&#xD;
           (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by&#xD;
           blinded independent central review (BICR)&#xD;
&#xD;
      As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants&#xD;
      still on treatment may have the option to continue receiving study intervention or SOC if&#xD;
      they are deriving clinical benefit, until criteria for discontinuation are met. Participants&#xD;
      who are still on study treatment and deriving clinical benefit will no longer have tumor&#xD;
      response assessments by BICR. However, local tumor imaging assessments should continue per&#xD;
      SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples&#xD;
      will no longer be collected.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 2, 2019</start_date>
  <completion_date type="Anticipated">September 29, 2023</completion_date>
  <primary_completion_date type="Actual">March 14, 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>Up to ~31 months</time_frame>
    <description>Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic Progression-Free Survival (rPFS)</measure>
    <time_frame>Up to ~31 months</time_frame>
    <description>rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (&gt;4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Initiation of the First Subsequent Anticancer Therapy (TFST)</measure>
    <time_frame>Up to ~31 months</time_frame>
    <description>TFST is the time from randomization to initiation of the first subsequent anticancer therapy defined as the first anti-cancer treatment not part of the study arm for a given participant, or death, whichever occurs first. The nonparametric Kaplan-Meier method was used to estimate the survival curves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Up to ~31 months</time_frame>
    <description>ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions per RECIST 1.1 and no evidence of disease (NED) bone scan) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 and Non-PD, non-evaluable (NE), or NED bone scan or CR with non-PD or NE bone scan.) The percentage of participants who experienced CR or PR as assessed by BICR is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to ~24 months</time_frame>
    <description>DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per PCWG-modified RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of ≥ 2 new bone lesions is also considered PD. DOR as assessed by BICR is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Prostate-Specific Antigen (PSA) Progression</measure>
    <time_frame>Up to ~31 months</time_frame>
    <description>Time to PSA progression is defined as the time from randomization to PSA progression. PSA progression date is defined as the date of:&#xD;
1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline, OR 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. The nonparametric Kaplan-Meier method was used to estimate the survival curves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Symptomatic Skeletal-Related Event (SSRE)</measure>
    <time_frame>Up to ~31 months</time_frame>
    <description>SSRE is defined as the time from randomization to the first symptomatic skeletal-related event, defined as whichever occurs first:&#xD;
First use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms;&#xD;
Occurrence of new symptomatic pathologic bone fracture (vertebral or nonvertebral);&#xD;
Occurrence of spinal cord compression; or&#xD;
Tumor-related orthopedic surgical intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Radiographic Soft Tissue Progression</measure>
    <time_frame>Up to ~31 months</time_frame>
    <description>Time to radiographic soft tissue progression is defined as the time from randomization to radiographic soft tissue progression per soft tissue rule of PCWG-modified RECIST 1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Time to radiographic soft tissue progression as assessed by BICR is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Pain Progression (TTPP)</measure>
    <time_frame>Up to ~31 months</time_frame>
    <description>TTPP is defined as the time from randomization to pain progression as determined by Item 3 of the Brief Pain Inventory Short Form (BPI-SF) and by the Analgesic Quantification Algorithm (AQA) score.&#xD;
Pain progression is defined as:&#xD;
For participants who are asymptomatic at baseline, a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain&#xD;
For participants who are symptomatic at baseline (average BPI-SF Item 3 score &gt;0 and/or currently taking opioids), a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits.&#xD;
Participants who had more than 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experience an Adverse Event (AE)</measure>
    <time_frame>Up to ~31 months</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an adverse event are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)</measure>
    <time_frame>Up to ~880 Days</time_frame>
    <description>The number of participants who discontinue study treatment due to an AE are presented.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">793</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab + Olaparib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Next-generation Hormonal Agent Monotherapy (NHA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive a single NHA, which will be either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Pembrolizumab + Olaparib</arm_group_label>
    <other_name>MK-3475</other_name>
    <other_name>KEYTRUDA®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olaparib</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Pembrolizumab + Olaparib</arm_group_label>
    <other_name>MK-7339</other_name>
    <other_name>AZD-2281</other_name>
    <other_name>LYNPARZA®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Next-generation Hormonal Agent Monotherapy (NHA)</arm_group_label>
    <other_name>ZYTIGA®</other_name>
    <other_name>CB-7630</other_name>
    <other_name>JNJ-212082</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Next-generation Hormonal Agent Monotherapy (NHA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <description>Oral tablets or oral capsules</description>
    <arm_group_label>Next-generation Hormonal Agent Monotherapy (NHA)</arm_group_label>
    <other_name>XTANDI®</other_name>
    <other_name>MDV-3100</other_name>
    <other_name>ASP-9785</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Next-generation Hormonal Agent Monotherapy (NHA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without&#xD;
             small cell histology&#xD;
&#xD;
          -  Has prostate cancer progression while receiving androgen deprivation therapy (or post&#xD;
             bilateral orchiectomy) within 6 months before screening&#xD;
&#xD;
          -  Has current evidence of metastatic disease documented by bone lesions on bone scan&#xD;
             and/or soft tissue disease shown by computed tomography/magnetic resonance imaging&#xD;
             (CT/MRI)&#xD;
&#xD;
          -  Has received prior treatment with abiraterone acetate OR enzalutamide, but not both&#xD;
&#xD;
               -  Have disease that progressed during or after treatment with abiraterone acetate&#xD;
                  for either metastatic hormone-sensitive prostate cancer (mHSPC) or mCRP or&#xD;
                  enzalutamide for mCRPC for at least 8 weeks (at least 14 weeks for participants&#xD;
                  with bone progression)&#xD;
&#xD;
               -  Participants that received abiraterone acetate for mHSPC may not have received&#xD;
                  abiraterone acetate or enzalutamide for mCRPC&#xD;
&#xD;
          -  Have received docetaxel chemotherapy regimen for mCRPC and have had progressive&#xD;
             disease during or after treatment with docetaxel&#xD;
&#xD;
          -  Has ongoing androgen deprivation with serum testosterone &lt;50 ng/dL (&lt;2.0 nM)&#xD;
&#xD;
          -  If receiving bone resorptive therapy, including but not limited to bisphosphonates or&#xD;
             denosumab, must have been receiving stable doses before randomization&#xD;
&#xD;
          -  Must agree to refrain from donating sperm during the intervention period and for at&#xD;
             least the time needed to eliminate each study intervention after the last dose of&#xD;
             study intervention PLUS be abstinent from heterosexual intercourse OR must agree to&#xD;
             use contraception unless confirmed to be azoospermic&#xD;
&#xD;
          -  Contraception use by men should be consistent with local regulations regarding the&#xD;
             methods of contraception for those participating in clinical studies. If the&#xD;
             contraception requirements in the local label for any of the study interventions is&#xD;
             more stringent than the requirement above, the local label requirements are to be&#xD;
             followed.&#xD;
&#xD;
          -  Has provided tumor tissue from a fresh core or excisional biopsy (obtained within 12&#xD;
             months of screening) from soft tissue not previously irradiated. Samples from tumors&#xD;
             progressing at a prior site of radiation are allowed. Participants with bone-only or&#xD;
             bone-predominant disease may provide a bone biopsy sample&#xD;
&#xD;
          -  Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed&#xD;
             within 7 days of randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a known additional malignancy that is progressing or has required active treatment&#xD;
             in the last 3 years&#xD;
&#xD;
          -  Has an active autoimmune disease that has required systemic treatment in the past 2&#xD;
             years&#xD;
&#xD;
          -  Has a history of (noninfectious) pneumonitis requiring steroids, or has current&#xD;
             pneumonitis&#xD;
&#xD;
          -  Has known active human immunodeficiency virus (HIV), hepatitis B virus (e.g.,&#xD;
             hepatitis B surface antigen reactive) or hepatitis C virus (HCV) infection (e.g., HCV&#xD;
             RNA [qualitative] is detected)&#xD;
&#xD;
          -  Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis&#xD;
&#xD;
          -  Has a history of seizure or any condition that may predispose to seizure&#xD;
&#xD;
          -  Has a history of loss of consciousness within 12 months of screening&#xD;
&#xD;
          -  Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features&#xD;
             suggestive of MDS/AML&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy&#xD;
&#xD;
          -  Has (≥Grade 3) hypersensitivity to pembrolizumab and/or any of its excipients&#xD;
&#xD;
          -  Has known hypersensitivity to the components or excipients in olaparib, abiraterone&#xD;
             acetate, prednisone or prednisolone, or enzalutamide&#xD;
&#xD;
          -  Has symptomatic congestive heart failure (New York Heart Association Class III or IV&#xD;
             heart disease)&#xD;
&#xD;
          -  Has received an anticancer monoclonal antibody (mAb) before randomization&#xD;
&#xD;
          -  Has received prior treatment with olaparib or any other PARP inhibitor&#xD;
&#xD;
          -  Has received prior treatment with apalutamide or darolutamide&#xD;
&#xD;
          -  Has received prior treatment with enzalutamide or apalutamide for metastatic&#xD;
             hormone-sensitive prostate cancer&#xD;
&#xD;
          -  Has used herbal products that may have hormonal anti-prostate cancer activity and/or&#xD;
             are known to decrease PSA (e.g., saw palmetto) before the date of randomization&#xD;
&#xD;
          -  Has received prior treatment with radium or other therapeutic radiopharmaceuticals for&#xD;
             prostate cancer&#xD;
&#xD;
          -  Has received prior treatment with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, or&#xD;
             with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.,&#xD;
             CTLA-4, OX-40, or CD137)&#xD;
&#xD;
          -  Is currently receiving either strong or moderate inhibitors of cytochrome P450 [CYP]&#xD;
             (CYP3A4) that cannot be discontinued for the duration of the study&#xD;
&#xD;
          -  Has received a previous allogenic bone marrow transplant or double umbilical cord&#xD;
             transplantation (dUCBT) or a solid organ transplant&#xD;
&#xD;
          -  Has received a live vaccine within 30 days prior to the date of randomization&#xD;
&#xD;
          -  Is currently participating in or has participated in a study of an investigational&#xD;
             agent, or has used an investigational device, within 4 weeks before the date of&#xD;
             randomization&#xD;
&#xD;
          -  Has a bone &quot;superscan&quot;&#xD;
&#xD;
          -  Is expecting to father children within the projected duration of the study, starting&#xD;
             with the screening visit through 90 days after the last dose of study intervention&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Joseph Heritage Healthcare ( Site 0069)</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology/Oncology - Santa Monica ( Site 0081)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sibley Memorial Hospital ( Site 0096)</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Cancer Center at Augusta University ( Site 0026)</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quincy Medical Group ( Site 0021)</name>
      <address>
        <city>Quincy</city>
        <state>Illinois</state>
        <zip>62301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane Cancer Center ( Site 0066)</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005)</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Urology Research Associates ( Site 0076)</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Ctr. ( Site 0093)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute ( Site 0033)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMass Memorial Medical Center ( Site 0053)</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Ann Karmanos Cancer Institute ( Site 0077)</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System ( Site 0039)</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Frontier Cancer Center ( Site 0016)</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Cancer Specialists ( Site 0034)</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 ( Site 0092)</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Cancer Center ( Site 0048)</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center ( Site 0095)</name>
      <address>
        <city>Las Cruces</city>
        <state>New Mexico</state>
        <zip>88011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Medical Professionals of NY ( Site 0060)</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Center Cary ( Site 0010)</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center-Research ( Site 0097)</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Urology Group- Cincinnati ( Site 0094)</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Cleveland Seidman Cancer Center ( Site 0036)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Urologic Research Center ( Site 0070)</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute ( Site 0002)</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Institute ( Site 0052)</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blue Ridge Cancer Care ( Site 0086)</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance ( Site 0079)</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert and Medical College of Wisconsin ( Site 0045)</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)</name>
      <address>
        <city>Berazategui</city>
        <state>Buenos Aires</state>
        <zip>B1884BBF</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Diagnostico Urologico ( Site 1008)</name>
      <address>
        <city>Buenos Aires</city>
        <state>Caba</state>
        <zip>C1120AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Britanico de Buenos Aires ( Site 1006)</name>
      <address>
        <city>Buenos Aires</city>
        <state>Caba</state>
        <zip>C1280AEB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Parque ( Site 1002)</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000DSV</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigaciones Metabolicas ( Site 1011)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1012AAR</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Aleman ( Site 1004)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1118AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Medico Alexander Fleming ( Site 1010)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1426ANZ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEMAIC ( Site 1014)</name>
      <address>
        <city>Cordoba</city>
        <zip>X5008HHW</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Hospital ( Site 0158)</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macquarie University ( Site 0151)</name>
      <address>
        <city>Macquarie University</city>
        <state>New South Wales</state>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Port Macquarie Base Hospital ( Site 0153)</name>
      <address>
        <city>Port Macquarie</city>
        <state>New South Wales</state>
        <zip>2444</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calvary Mater Newcastle ( Site 0148)</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Medical Day Care Centre ( Site 0160)</name>
      <address>
        <city>Wollongong</city>
        <state>New South Wales</state>
        <zip>2500</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women s Hospital ( Site 0155)</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Flynn Hospital &amp; Medical Centre ( Site 0164)</name>
      <address>
        <city>Tugun</city>
        <state>Queensland</state>
        <zip>4224</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Box Hill Hospital ( Site 0146)</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Centre ( Site 0152)</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fiona Stanley Hospital ( Site 0162)</name>
      <address>
        <city>Murdoch</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)</name>
      <address>
        <city>Linz</city>
        <state>Oberosterreich</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitat Graz ( Site 0374)</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI-CCCIT GesmbH ( Site 0371)</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Wien ( Site 0375)</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Caridade de Ijui ( Site 1038)</name>
      <address>
        <city>Ijui</city>
        <state>Rio Grande Do Sul</state>
        <zip>98700-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)</name>
      <address>
        <city>Itajai</city>
        <state>Santa Catarina</state>
        <zip>88301-215</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Base de Sao Jose de Rio Preto ( Site 1022)</name>
      <address>
        <city>Sao Jose do Rio Preto</city>
        <state>Sao Paulo</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040)</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>04014-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.C. Camargo Cancer Center ( Site 1026)</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01509-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute ( Site 0110)</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113)</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 5L3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Cancer-Vancouver Center ( Site 0112)</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nova Scotia Health Authority QEII-HSC ( Site 0114)</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Osler Health System (Brampton Civic Hospital) ( Site 0121)</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6R 3J7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre ( Site 0107)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)</name>
      <address>
        <city>Rimouski</city>
        <state>Quebec</state>
        <zip>G5L 5T1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)</name>
      <address>
        <city>Quebec</city>
        <zip>G1R 2J6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Investigación del Cáncer James Lind ( Site 1041)</name>
      <address>
        <city>Temuco</city>
        <state>Araucania</state>
        <zip>4780000</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rey y Oreilly Limitada ( Site 1048)</name>
      <address>
        <city>Temuco</city>
        <state>Araucania</state>
        <zip>4810148</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Arturo Lopez Perez ( Site 1049)</name>
      <address>
        <city>Santiago</city>
        <state>Region M. De Santiago</state>
        <zip>7500921</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pontificia Universidad Catolica de Chile ( Site 1047)</name>
      <address>
        <city>Santiago</city>
        <state>Region M. De Santiago</state>
        <zip>8330032</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)</name>
      <address>
        <city>Santiago</city>
        <state>Region M. De Santiago</state>
        <zip>8420383</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H. de Saint Quentin ( Site 0481)</name>
      <address>
        <city>Saint Quentin</city>
        <state>Aisne</state>
        <zip>02321</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Sainte Anne ( Site 0431)</name>
      <address>
        <city>Strasbourg</city>
        <state>Alsace</state>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin ( Site 0434)</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Auvergne</state>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmettes ( Site 0419)</name>
      <address>
        <city>Marseille</city>
        <state>Bouches-du-Rhone</state>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Brest -Site Hopital Morvan ( Site 0441)</name>
      <address>
        <city>Brest</city>
        <state>Bretagne</state>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Jean Minjoz ( Site 0423)</name>
      <address>
        <city>Besancon</city>
        <state>Doubs</state>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie ( Site 0421)</name>
      <address>
        <city>Bordeaux</city>
        <state>Gironde</state>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud IUCT Oncopole ( Site 0418)</name>
      <address>
        <city>Toulouse</city>
        <state>Haute-Garonne</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Foch ( Site 0428)</name>
      <address>
        <city>Suresnes</city>
        <state>Hauts-de-Seine</state>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Regional du Cancer de Montpellier - ICM ( Site 0443)</name>
      <address>
        <city>Montpellier</city>
        <state>Herault</state>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut De Cancerologie De L Ouest ( Site 0448)</name>
      <address>
        <city>Saint Herblain</city>
        <state>Loire-Atlantique</state>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Regional du Orleans ( Site 0430)</name>
      <address>
        <city>Orleans</city>
        <state>Loiret</state>
        <zip>45100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre D Oncologie de Gentilly ( Site 0432)</name>
      <address>
        <city>Nancy</city>
        <state>Meurthe-et-Moselle</state>
        <zip>54100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard ( Site 0422)</name>
      <address>
        <city>Lyon</city>
        <state>Rhone</state>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H.U. Lyon Sud ( Site 0436)</name>
      <address>
        <city>Pierre Benite</city>
        <state>Rhone</state>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Amiens Picardie Site Sud Amiens ( Site 0438)</name>
      <address>
        <city>Amiens</city>
        <state>Somme</state>
        <zip>80000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy ( Site 0416)</name>
      <address>
        <city>Villejuif</city>
        <state>Val-de-Marne</state>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Sainte Catherine ( Site 0447)</name>
      <address>
        <city>Avignon</city>
        <state>Vaucluse</state>
        <zip>84000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris ( Site 0446)</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)</name>
      <address>
        <city>Freiburg</city>
        <state>Baden-Wurttemberg</state>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum in Mannheim ( Site 0314)</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Wurttemberg</state>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienpraxis Urologie ( Site 0309)</name>
      <address>
        <city>Nuertingen</city>
        <state>Baden-Wurttemberg</state>
        <zip>72622</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinik fuer Urologie ( Site 0307)</name>
      <address>
        <city>Tuebingen</city>
        <state>Baden-Wurttemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Erlangen ( Site 0303)</name>
      <address>
        <city>Erlangen</city>
        <state>Bayern</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Rechts der Isar ( Site 0300)</name>
      <address>
        <city>Muenchen</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)</name>
      <address>
        <city>Nuernberg</city>
        <state>Bayern</state>
        <zip>90419</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Duesseldorf ( Site 0306)</name>
      <address>
        <city>Duesseldorf</city>
        <state>Nordrhein-Westfalen</state>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)</name>
      <address>
        <city>Trier</city>
        <state>Rheinland-Pfalz</state>
        <zip>54292</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Jena ( Site 0305)</name>
      <address>
        <city>Jena</city>
        <state>Thuringen</state>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301)</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallaght University Hospital ( Site 0730)</name>
      <address>
        <city>Dublin</city>
        <zip>D24 NROA</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Western Cancer Centre ( Site 0728)</name>
      <address>
        <city>Limerick</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ha Emek Medical Center ( Site 0548)</name>
      <address>
        <city>Afula</city>
        <zip>1834111</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofe ( Site 0547)</name>
      <address>
        <city>Be'er- Ya'akov</city>
        <zip>7030001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center ( Site 0549)</name>
      <address>
        <city>Beer Sheva</city>
        <zip>8410101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center ( Site 0543)</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Ein Kerem Medical Center ( Site 0546)</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center ( Site 0544)</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center ( Site 0545)</name>
      <address>
        <city>Petach-Tikwa</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center ( Site 0541)</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5262000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center ( Site 0542)</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0462)</name>
      <address>
        <city>Meldola</city>
        <state>Emilia-Romagna</state>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas Research Hospital ( Site 0452)</name>
      <address>
        <city>Rozzano</city>
        <state>Lombardia</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology Ospedale San Donato ( Site 0461)</name>
      <address>
        <city>Arezzo</city>
        <zip>52100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico S.Orsola-Malpighi ( Site 0453)</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Cannizzaro ( Site 0458)</name>
      <address>
        <city>Catania</city>
        <zip>95126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Camillo Forlanini ( Site 0455)</name>
      <address>
        <city>Roma</city>
        <zip>00152</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A. Gemelli ( Site 0463)</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Santa Maria Terni ( Site 0456)</name>
      <address>
        <city>Terni</city>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero Santa Chiara ( Site 0451)</name>
      <address>
        <city>Trento</city>
        <zip>38122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital ( Site 0724)</name>
      <address>
        <city>Toyoake</city>
        <state>Aichi</state>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East ( Site 0702)</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Sakura Medical Center ( Site 0703)</name>
      <address>
        <city>Sakura</city>
        <state>Chiba</state>
        <zip>285-8741</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Shikoku Cancer Center ( Site 0716)</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <zip>791-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital ( Site 0726)</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital ( Site 0701)</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kitasato University Hospital ( Site 0705)</name>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <zip>252-0375</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Medical Center ( Site 0706)</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>232-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nara Medical University Hospital ( Site 0715)</name>
      <address>
        <city>Kashihara</city>
        <state>Nara</state>
        <zip>634-8522</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital ( Site 0714)</name>
      <address>
        <city>Osakasayama</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital ( Site 0713)</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University International Medical Center ( Site 0708)</name>
      <address>
        <city>Hidaka</city>
        <state>Saitama</state>
        <zip>350-1298</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Saitama Medical Center ( Site 0707)</name>
      <address>
        <city>Koshigaya</city>
        <state>Saitama</state>
        <zip>343-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fuji City General Hospital ( Site 0725)</name>
      <address>
        <city>Fuji</city>
        <state>Shizuoka</state>
        <zip>417-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamamatsu University Hospital ( Site 0720)</name>
      <address>
        <city>Hamamatsu</city>
        <state>Shizuoka</state>
        <zip>431-3192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamaguchi University Hospital ( Site 0717)</name>
      <address>
        <city>Ube</city>
        <state>Yamaguchi</state>
        <zip>755-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center ( Site 0704)</name>
      <address>
        <city>Chiba</city>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital ( Site 0718)</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miyazaki Hospital ( Site 0721)</name>
      <address>
        <city>Miyazaki</city>
        <zip>889-1692</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagano Municipal Hospital ( Site 0723)</name>
      <address>
        <city>Nagano</city>
        <zip>381-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital ( Site 0719)</name>
      <address>
        <city>Nagasaki</city>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute ( Site 0722)</name>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toranomon Hospital ( Site 0711)</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8470</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital ( Site 0709)</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital ( Site 0710)</name>
      <address>
        <city>Tokyo</city>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital ( Site 0174)</name>
      <address>
        <city>Hwasun Gun</city>
        <state>Jeonranamdo</state>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center ( Site 0176)</name>
      <address>
        <city>Goyang-si</city>
        <state>Kyonggi-do</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center ( Site 0171)</name>
      <address>
        <city>Songpagu</city>
        <state>Seoul</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital Yonsei University Health System ( Site 0173)</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center ( Site 0172)</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden ( Site 0477)</name>
      <address>
        <city>Leeuwarden</city>
        <state>Fryslan</state>
        <zip>8934 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud University Medical Center ( Site 0470)</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vrije Universiteit Medisch Centrum ( Site 0479)</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spaarne Ziekenhuis ( Site 0473)</name>
      <address>
        <city>Hoofddorp</city>
        <state>Noord-Holland</state>
        <zip>2134 TM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuisgroep Twente ( Site 0469)</name>
      <address>
        <city>Hengelo</city>
        <state>Overijssel</state>
        <zip>7555 DL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haaglanden MC - locatie Antoniushove ( Site 0471)</name>
      <address>
        <city>Leidschendam</city>
        <state>Zuid-Holland</state>
        <zip>2262 BA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC ( Site 0475)</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscus Gasthuis en Vlietland ( Site 0489)</name>
      <address>
        <city>Schiedam</city>
        <state>Zuid-Holland</state>
        <zip>3118 JH</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital ( Site 0193)</name>
      <address>
        <city>Auckland</city>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)</name>
      <address>
        <city>Chelyabinsk</city>
        <state>Chelyabinskaya Oblast</state>
        <zip>454087</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)</name>
      <address>
        <city>Krasnoyarsk</city>
        <state>Krasnoyarskiy Kray</state>
        <zip>660133</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Scientific Center of Roentgenoradiology ( Site 0559)</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Clinical Hospital with Polyclinic ( Site 0562)</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>121359</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omsk Clinical Oncology Dispensary ( Site 0568)</name>
      <address>
        <city>Omsk</city>
        <state>Omskaya Oblast</state>
        <zip>644013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)</name>
      <address>
        <city>Samara</city>
        <state>Samarskaya Oblast</state>
        <zip>443031</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBHI Leningrad Regional Oncology Dispensary ( Site 0588)</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>191104</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of specialized types medical care-Oncology ( Site 0570)</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)</name>
      <address>
        <city>Tomsk</city>
        <state>Tomskaya Oblast</state>
        <zip>634028</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Catalan de Oncologia - ICO ( Site 0330)</name>
      <address>
        <city>L Hospitalet De Llobregat</city>
        <state>Barcelona</state>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Parc Tauli ( Site 0335)</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro de Alcantara ( Site 0326)</name>
      <address>
        <city>Caceres</city>
        <state>Extremadura</state>
        <zip>10003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Josep Trueta ( Site 0321)</name>
      <address>
        <city>Girona</city>
        <state>Gerona</state>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quiron Madrid ( Site 0325)</name>
      <address>
        <city>Pozuelo de Alarcon</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar ( Site 0333)</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitari Vall d Hebron ( Site 0334)</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic ( Site 0323)</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Victoria ( Site 0337)</name>
      <address>
        <city>Malaga</city>
        <zip>29016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital ( Site 0134)</name>
      <address>
        <city>Tainen</city>
        <state>Tainan</state>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital ( Site 0132)</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital ( Site 0133)</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital ( Site 0131)</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital ( Site 0135)</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Bristol NHS Foundation Trust ( Site 0530)</name>
      <address>
        <city>Bristol</city>
        <state>Bristol, City Of</state>
        <zip>BS2 8ED</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cambridge University Hospitals NHS Trust ( Site 0540)</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torbay Hospital ( Site 0532)</name>
      <address>
        <city>Torquay</city>
        <state>Devon</state>
        <zip>TQ2 7AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital ( Site 0526)</name>
      <address>
        <city>Sutton</city>
        <state>England</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Musgrove Park Hospital ( Site 0537)</name>
      <address>
        <city>Taunton</city>
        <state>England</state>
        <zip>TA1 5DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Midlands NHS Foundation Trust ( Site 0527)</name>
      <address>
        <city>Stoke-on-Trent</city>
        <state>Staffordshire</state>
        <zip>ST4 6QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Cancer Centre ( Site 0536)</name>
      <address>
        <city>Northwood</city>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.merckclinicaltrials.com/</url>
    <description>Merck Clinical Trials Information</description>
  </link>
  <results_reference>
    <citation>Antonarakis ES, Park SH, Goh JC, Shin SJ, Lee JL, Mehra N, McDermott R, Sala-Gonzalez N, Fong PC, Greil R, Retz M, Sade JP, Yanez P, Huang YH, Begbie SD, Gafanov RA, De Santis M, Rosenbaum E, Kolinsky MP, Rey F, Chiu KY, Roubaud G, Kramer G, Sumitomo M, Massari F, Suzuki H, Qiu P, Zhang J, Kim J, Poehlein CH, Yu EY. Pembrolizumab Plus Olaparib for Patients With Previously Treated and Biomarker-Unselected Metastatic Castration-Resistant Prostate Cancer: The Randomized, Open-Label, Phase III KEYLYNK-010 Trial. J Clin Oncol. 2023 Aug 1;41(22):3839-3850. doi: 10.1200/JCO.23.00233. Epub 2023 Jun 8.</citation>
    <PMID>37290035</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <results_first_submitted>March 2, 2023</results_first_submitted>
  <results_first_submitted_qc>April 18, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 20, 2023</results_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Programmed Cell Death-1 (PD1, PD-1)</keyword>
  <keyword>Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)</keyword>
  <keyword>Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Olaparib</mesh_term>
    <mesh_term>Abiraterone Acetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <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>May 2, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03834519/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants randomized to the next-generation hormonal agent monotherapy (NHA) arm received one of two NHA treatments, per protocol.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pembrolizumab + Olaparib</title>
          <description>Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).</description>
        </group>
        <group group_id="P2">
          <title>Next-generation Hormonal Agent Monotherapy (NHA)</title>
          <description>Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="529"/>
                <participants group_id="P2" count="264"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="529"/>
                <participants group_id="P2" count="264"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Ongoing</title>
              <participants_list>
                <participants group_id="P1" count="234"/>
                <participants group_id="P2" count="111"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="291"/>
                <participants group_id="P2" count="146"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pembrolizumab + Olaparib</title>
          <description>Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).</description>
        </group>
        <group group_id="B2">
          <title>Next-generation Hormonal Agent Monotherapy (NHA)</title>
          <description>Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.</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="529"/>
            <count group_id="B2" value="264"/>
            <count group_id="B3" value="793"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.9" spread="7.4"/>
                    <measurement group_id="B2" value="69.1" spread="7.3"/>
                    <measurement group_id="B3" value="69.6" spread="7.4"/>
                  </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="529"/>
                    <measurement group_id="B2" value="264"/>
                    <measurement group_id="B3" value="793"/>
                  </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="71"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="441"/>
                    <measurement group_id="B2" value="219"/>
                    <measurement group_id="B3" value="660"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="161"/>
                  </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="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="419"/>
                    <measurement group_id="B2" value="199"/>
                    <measurement group_id="B3" value="618"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Measurable Response Evaluation Criteria in Solid Tumors Version 1.1 Disease Status at Baseline</title>
          <description>Measurable disease at baseline is defined as having disease that is Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)-measurable lesions per blinded independent central review (BICR).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>RECIST Measurable: Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="244"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RECIST Measurable: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="285"/>
                    <measurement group_id="B2" value="145"/>
                    <measurement group_id="B3" value="430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Use of NHA Treatment</title>
          <description>Prior use of NHA treatment was defined as prior treatment with Abiraterone only, Enzalutamide only, or Abiraterone and Enzalutamide.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Abiraterone only</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="289"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enzalutamide only</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="240"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="360"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abiraterone and Enzalutamide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves.</description>
        <time_frame>Up to ~31 months</time_frame>
        <population>All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Olaparib</title>
            <description>Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).</description>
          </group>
          <group group_id="O2">
            <title>Next-generation Hormonal Agent Monotherapy (NHA)</title>
            <description>Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves.</description>
          <population>All randomized participants.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="529"/>
                <count group_id="O2" value="264"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8" lower_limit="14.6" upper_limit="17.0"/>
                    <measurement group_id="O2" value="14.6" lower_limit="12.6" upper_limit="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Treatment difference in survival assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2616</p_value>
            <method>Log Rank</method>
            <method_desc>One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
            <estimate_desc>Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Radiographic Progression-Free Survival (rPFS)</title>
        <description>rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (&gt;4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves.</description>
        <time_frame>Up to ~31 months</time_frame>
        <population>All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Olaparib</title>
            <description>Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).</description>
          </group>
          <group group_id="O2">
            <title>Next-generation Hormonal Agent Monotherapy (NHA)</title>
            <description>Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic Progression-Free Survival (rPFS)</title>
          <description>rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (&gt;4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves.</description>
          <population>All randomized participants.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="529"/>
                <count group_id="O2" value="264"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" lower_limit="4.2" upper_limit="6.0"/>
                    <measurement group_id="O2" value="4.2" lower_limit="4.0" upper_limit="6.1"/>
                  </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>Treatment difference in rPFS assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5544</p_value>
            <method>Log Rank</method>
            <method_desc>One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
            <estimate_desc>Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Initiation of the First Subsequent Anticancer Therapy (TFST)</title>
        <description>TFST is the time from randomization to initiation of the first subsequent anticancer therapy defined as the first anti-cancer treatment not part of the study arm for a given participant, or death, whichever occurs first. The nonparametric Kaplan-Meier method was used to estimate the survival curves.</description>
        <time_frame>Up to ~31 months</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions per RECIST 1.1 and no evidence of disease (NED) bone scan) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 and Non-PD, non-evaluable (NE), or NED bone scan or CR with non-PD or NE bone scan.) The percentage of participants who experienced CR or PR as assessed by BICR is presented.</description>
        <time_frame>Up to ~31 months</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per PCWG-modified RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of ≥ 2 new bone lesions is also considered PD. DOR as assessed by BICR is presented.</description>
        <time_frame>Up to ~24 months</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Prostate-Specific Antigen (PSA) Progression</title>
        <description>Time to PSA progression is defined as the time from randomization to PSA progression. PSA progression date is defined as the date of:&#xD;
1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline, OR 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. The nonparametric Kaplan-Meier method was used to estimate the survival curves.</description>
        <time_frame>Up to ~31 months</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Symptomatic Skeletal-Related Event (SSRE)</title>
        <description>SSRE is defined as the time from randomization to the first symptomatic skeletal-related event, defined as whichever occurs first:&#xD;
First use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms;&#xD;
Occurrence of new symptomatic pathologic bone fracture (vertebral or nonvertebral);&#xD;
Occurrence of spinal cord compression; or&#xD;
Tumor-related orthopedic surgical intervention</description>
        <time_frame>Up to ~31 months</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Radiographic Soft Tissue Progression</title>
        <description>Time to radiographic soft tissue progression is defined as the time from randomization to radiographic soft tissue progression per soft tissue rule of PCWG-modified RECIST 1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Time to radiographic soft tissue progression as assessed by BICR is presented.</description>
        <time_frame>Up to ~31 months</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Pain Progression (TTPP)</title>
        <description>TTPP is defined as the time from randomization to pain progression as determined by Item 3 of the Brief Pain Inventory Short Form (BPI-SF) and by the Analgesic Quantification Algorithm (AQA) score.&#xD;
Pain progression is defined as:&#xD;
For participants who are asymptomatic at baseline, a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain&#xD;
For participants who are symptomatic at baseline (average BPI-SF Item 3 score &gt;0 and/or currently taking opioids), a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits.&#xD;
Participants who had more than 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.</description>
        <time_frame>Up to ~31 months</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experience an Adverse Event (AE)</title>
        <description>An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an adverse event are presented.</description>
        <time_frame>Up to ~31 months</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)</title>
        <description>The number of participants who discontinue study treatment due to an AE are presented.</description>
        <time_frame>Up to ~880 Days</time_frame>
        <posting_date>09/2024</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>For All-Cause Mortality: from allocation up to ~31 months. For AEs from start of treatment up to ~31 months.</time_frame>
      <desc>All-cause mortality: All allocated participants. AEs: All allocated participants who received ≥1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. MedDRA preferred terms &quot;Neoplasm progression&quot;, &quot;Malignant neoplasm progression&quot; and &quot;Disease progression&quot; not related to study drug are excluded as AEs. The next-generation hormonal agent monotherapy interventions are considered standard of care (SOC).</desc>
      <group_list>
        <group group_id="E1">
          <title>Pembrolizumab + Olaparib</title>
          <description>Participants received olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).</description>
        </group>
        <group group_id="E2">
          <title>Next-generation Hormonal Agent Monotherapy (NHA)</title>
          <description>Participants received a single NHA of either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR participants received enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="293" subjects_at_risk="529"/>
                <counts group_id="E2" subjects_affected="149" subjects_at_risk="264"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="168" subjects_at_risk="526"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="256"/>
              </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="20" subjects_affected="18" subjects_at_risk="526"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Anaemia of malignant disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </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="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Mechanical ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Neutropenic colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Oesophageal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pneumoperitoneum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Gallbladder disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Immune-mediated hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Infective spondylitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="526"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Prostatitis Escherichia coli</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="526"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Gastroenteritis radiation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Ilium fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Radiation proctitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>SARS-CoV-2 test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </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="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="526"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of jaw</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Polyarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Polymyalgia rheumatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Spinal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Paraplegia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </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="3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Haemorrhage urinary tract</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Postrenal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pyelocaliectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Ureteric stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="526"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Immune-mediated lung disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Toxic epidermal necrolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="526"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Toxic skin eruption</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="526"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="490" subjects_at_risk="526"/>
                <counts group_id="E2" subjects_affected="212" subjects_at_risk="256"/>
              </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="322" subjects_affected="271" subjects_at_risk="526"/>
                <counts group_id="E2" events="37" subjects_affected="35" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="53" subjects_affected="52" subjects_at_risk="526"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="112" subjects_affected="100" subjects_at_risk="526"/>
                <counts group_id="E2" events="45" subjects_affected="42" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="129" subjects_affected="101" subjects_at_risk="526"/>
                <counts group_id="E2" events="26" subjects_affected="22" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="272" subjects_affected="221" subjects_at_risk="526"/>
                <counts group_id="E2" events="49" subjects_affected="45" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="143" subjects_affected="90" subjects_at_risk="526"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="106" subjects_affected="92" subjects_at_risk="526"/>
                <counts group_id="E2" events="28" subjects_affected="26" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="195" subjects_affected="184" subjects_at_risk="526"/>
                <counts group_id="E2" events="67" subjects_affected="66" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="48" subjects_affected="44" subjects_at_risk="526"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="57" subjects_affected="50" subjects_at_risk="526"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="33" subjects_affected="26" subjects_at_risk="526"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="28" subjects_affected="27" subjects_at_risk="526"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="44" subjects_affected="36" subjects_at_risk="526"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="33" subjects_affected="32" subjects_at_risk="526"/>
                <counts group_id="E2" events="27" subjects_affected="24" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="51" subjects_affected="44" subjects_at_risk="526"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="67" subjects_affected="65" subjects_at_risk="526"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="256"/>
              </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="169" subjects_affected="150" subjects_at_risk="526"/>
                <counts group_id="E2" events="50" subjects_affected="44" subjects_at_risk="256"/>
              </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="115" subjects_affected="94" subjects_at_risk="526"/>
                <counts group_id="E2" events="46" subjects_affected="37" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="91" subjects_affected="81" subjects_at_risk="526"/>
                <counts group_id="E2" events="48" subjects_affected="43" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="42" subjects_affected="34" subjects_at_risk="526"/>
                <counts group_id="E2" events="26" subjects_affected="25" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="35" subjects_affected="33" subjects_at_risk="526"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="37" subjects_affected="33" subjects_at_risk="526"/>
                <counts group_id="E2" events="31" subjects_affected="23" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="51" subjects_affected="43" subjects_at_risk="526"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="32" subjects_affected="31" subjects_at_risk="526"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="36" subjects_affected="29" subjects_at_risk="526"/>
                <counts group_id="E2" events="19" subjects_affected="13" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="25" subjects_affected="23" subjects_at_risk="526"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="256"/>
              </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="51" subjects_affected="42" subjects_at_risk="526"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="256"/>
              </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="46" subjects_affected="41" subjects_at_risk="526"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="49" subjects_affected="38" subjects_at_risk="526"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="256"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="526"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="256"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="33" subjects_affected="27" subjects_at_risk="526"/>
                <counts group_id="E2" events="32" subjects_affected="31" subjects_at_risk="256"/>
              </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>If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme LLC</organization>
      <phone>1-800-672-6372</phone>
      <email>Clinicaltrialsdisclosure@merck.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/NCT03834519
org study id: 7339-010
secondary id: MK-7339-010
secondary id: KEYLYNK-010
secondary id: 2018-004118-16
nct id: NCT03834519
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the efficacy and safety of the combination of the
      polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and
      pembrolizumab in the treatment of participants with mCRPC who have failed to respond to
      either abiraterone acetate or enzalutamide (but not both) and to chemotherapy.

      The primary study hypotheses are that the combination of pembrolizumab plus olaparib is
      superior to abiraterone acetate or enzalutamide with respect to:

        1. Overall Survival (OS) and

        2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group
           (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by
           blinded independent central review (BICR)

      As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants
      still on treatment may have the option to continue receiving study intervention or SOC if
      they are deriving clinical benefit, until criteria for discontinuation are met. Participants
      who are still on study treatment and deriving clinical benefit will no longer have tumor
      response assessments by BICR. However, local tumor imaging assessments should continue per
      SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples
      will no longer be collected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS)
time frame: Up to ~31 months
description: Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
measure: Radiographic Progression-Free Survival (rPFS)
time frame: Up to ~31 months
description: rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
measure: Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
time frame: Up to ~31 months
description: TFST is the time from randomization to initiation of the first subsequent anticancer therapy defined as the first anti-cancer treatment not part of the study arm for a given participant, or death, whichever occurs first. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
measure: Objective Response Rate (ORR)
time frame: Up to ~31 months
description: ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions per RECIST 1.1 and no evidence of disease (NED) bone scan) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 and Non-PD, non-evaluable (NE), or NED bone scan or CR with non-PD or NE bone scan.) The percentage of participants who experienced CR or PR as assessed by BICR is presented.
measure: Duration of Response (DOR)
time frame: Up to ~24 months
description: DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per PCWG-modified RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of ≥ 2 new bone lesions is also considered PD. DOR as assessed by BICR is presented.
measure: Time to Prostate-Specific Antigen (PSA) Progression
time frame: Up to ~31 months
description: Time to PSA progression is defined as the time from randomization to PSA progression. PSA progression date is defined as the date of:
1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline, OR 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
measure: Time to First Symptomatic Skeletal-Related Event (SSRE)
time frame: Up to ~31 months
description: SSRE is defined as the time from randomization to the first symptomatic skeletal-related event, defined as whichever occurs first:
First use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms;
Occurrence of new symptomatic pathologic bone fracture (vertebral or nonvertebral);
Occurrence of spinal cord compression; or
Tumor-related orthopedic surgical intervention
measure: Time to Radiographic Soft Tissue Progression
time frame: Up to ~31 months
description: Time to radiographic soft tissue progression is defined as the time from randomization to radiographic soft tissue progression per soft tissue rule of PCWG-modified RECIST 1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Time to radiographic soft tissue progression as assessed by BICR is presented.
measure: Time to Pain Progression (TTPP)
time frame: Up to ~31 months
description: TTPP is defined as the time from randomization to pain progression as determined by Item 3 of the Brief Pain Inventory Short Form (BPI-SF) and by the Analgesic Quantification Algorithm (AQA) score.
Pain progression is defined as:
For participants who are asymptomatic at baseline, a ≥2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain
For participants who are symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids), a ≥2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score ≥4 and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits.
Participants who had more than 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.
measure: Number of Participants Who Experience an Adverse Event (AE)
time frame: Up to ~31 months
description: An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an adverse event are presented.
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
time frame: Up to ~880 Days
description: The number of participants who discontinue study treatment due to an AE are presented.
arm group label: Pembrolizumab + Olaparib
arm group type: Experimental
description: Participants will receive olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
arm group label: Next-generation Hormonal Agent Monotherapy (NHA)
arm group type: Active Comparator
description: Participants will receive a single NHA, which will be either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
intervention type: Biological
intervention name: Pembrolizumab
description: IV infusion
arm group label: Pembrolizumab + Olaparib
other name: MK-3475
other name: KEYTRUDA®
intervention type: Drug
intervention name: Olaparib
description: Oral tablets
arm group label: Pembrolizumab + Olaparib
other name: MK-7339
other name: AZD-2281
other name: LYNPARZA®
intervention type: Drug
intervention name: Abiraterone acetate
description: Oral tablets
arm group label: Next-generation Hormonal Agent Monotherapy (NHA)
other name: ZYTIGA®
other name: CB-7630
other name: JNJ-212082
intervention type: Drug
intervention name: Prednisone
description: Oral tablets
arm group label: Next-generation Hormonal Agent Monotherapy (NHA)
intervention type: Drug
intervention name: Enzalutamide
description: Oral tablets or oral capsules
arm group label: Next-generation Hormonal Agent Monotherapy (NHA)
other name: XTANDI®
other name: MDV-3100
other name: ASP-9785
intervention type: Drug
intervention name: Prednisolone
description: Oral tablets
arm group label: Next-generation Hormonal Agent Monotherapy (NHA)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
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country: Argentina
country: Australia
country: Austria
country: Brazil
country: Canada
country: Chile
country: France
country: Germany
country: Ireland
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: New Zealand
country: Russian Federation
country: Spain
country: Taiwan
country: United Kingdom
country: United States
url: https://www.merckclinicaltrials.com/
description: Merck Clinical Trials Information
citation: Antonarakis ES, Park SH, Goh JC, Shin SJ, Lee JL, Mehra N, McDermott R, Sala-Gonzalez N, Fong PC, Greil R, Retz M, Sade JP, Yanez P, Huang YH, Begbie SD, Gafanov RA, De Santis M, Rosenbaum E, Kolinsky MP, Rey F, Chiu KY, Roubaud G, Kramer G, Sumitomo M, Massari F, Suzuki H, Qiu P, Zhang J, Kim J, Poehlein CH, Yu EY. Pembrolizumab Plus Olaparib for Patients With Previously Treated and Biomarker-Unselected Metastatic Castration-Resistant Prostate Cancer: The Randomized, Open-Label, Phase III KEYLYNK-010 Trial. J Clin Oncol. 2023 Aug 1;41(22):3839-3850. doi: 10.1200/JCO.23.00233. Epub 2023 Jun 8.
PMID: 37290035
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prednisone
mesh term: Prednisolone
mesh term: Pembrolizumab
mesh term: Olaparib
mesh term: Abiraterone Acetate
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 