<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/NCT03834506</url>
  </required_header>
  <id_info>
    <org_study_id>3475-921</org_study_id>
    <secondary_id>MK-3475-921</secondary_id>
    <secondary_id>KEYNOTE-921</secondary_id>
    <secondary_id>JAPAC-CTI</secondary_id>
    <secondary_id>2018-004116-22</secondary_id>
    <nct_id>NCT03834506</nct_id>
  </id_info>
  <brief_title>Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)</brief_title>
  <official_title>A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)</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&#xD;
      pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic&#xD;
      castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but&#xD;
      have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).&#xD;
&#xD;
      There are two primary study hypotheses.&#xD;
&#xD;
      Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to&#xD;
      placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).&#xD;
&#xD;
      Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to&#xD;
      placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival&#xD;
      (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in&#xD;
      Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With Amendment 6 (effective date: 29-Sep-2022), all participants will be unblinded and&#xD;
      placebo treatment will be stopping. Participants who are deemed to be deriving clinical&#xD;
      benefit from treatment may continue at the discretion of the investigator.&#xD;
&#xD;
      The global study for MK-3475-921 enrolled 1030 participants. Of the 1030 total participants&#xD;
      enrolled in the global study, 21 were also enrolled in the China extension study for&#xD;
      MK-3475-921 (NCT04907227).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2019</start_date>
  <completion_date type="Actual">July 18, 2023</completion_date>
  <primary_completion_date type="Actual">June 20, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 36.5 months</time_frame>
    <description>OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)</measure>
    <time_frame>Up to approximately 28 months</time_frame>
    <description>rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)</measure>
    <time_frame>Up to approximately 28 months</time_frame>
    <description>TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit (Kaplan-Meier) method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate-specific Antigen (PSA) Response Rate</measure>
    <time_frame>Up to 36.5 months</time_frame>
    <description>The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review</measure>
    <time_frame>Up to 36.5 months</time_frame>
    <description>ORR was 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) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review</measure>
    <time_frame>Up to 36.5 months</time_frame>
    <description>DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was 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. PD per PCWG was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for ≥6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (&quot;Worst Pain in 24 Hours&quot;) and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score</measure>
    <time_frame>Up to 36.5 months</time_frame>
    <description>TTPP was defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF and by the AQA score. Pain progression was defined as:&#xD;
For participants 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 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;
TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had &gt; 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Symptomatic Skeletal-related Event (SSRE)</measure>
    <time_frame>Up to 36.5 months</time_frame>
    <description>SSRE was the time from randomization to the first symptomatic skeletal-related event defined as:&#xD;
Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms&#xD;
Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral)&#xD;
Occurrence of spinal cord compression&#xD;
Tumor-related orthopedic surgical intervention, whichever occurs first.&#xD;
The SSRE was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Prostate-specific Antigen (PSA) Progression</measure>
    <time_frame>Up to 36.5 months</time_frame>
    <description>The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of:&#xD;
≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR&#xD;
≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline&#xD;
Time to PSA progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)</measure>
    <time_frame>Up to 36.5 months</time_frame>
    <description>The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was 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 was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced an Adverse Event (AE)</measure>
    <time_frame>Up to approximately 30 months</time_frame>
    <description>An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)</measure>
    <time_frame>Up to approximately 27 months</time_frame>
    <description>An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1030</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab+Docetaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo+Docetaxel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Pembrolizumab+Docetaxel</arm_group_label>
    <other_name>MK-3475</other_name>
    <other_name>KEYTRUDA®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Pembrolizumab+Docetaxel</arm_group_label>
    <arm_group_label>Placebo+Docetaxel</arm_group_label>
    <other_name>TAXOTERE®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Pembrolizumab+Docetaxel</arm_group_label>
    <arm_group_label>Placebo+Docetaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Placebo+Docetaxel</arm_group_label>
    <other_name>Normal saline or dextrose infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Pembrolizumab+Docetaxel</arm_group_label>
    <arm_group_label>Placebo+Docetaxel</arm_group_label>
    <other_name>DECADRON®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The main inclusion and exclusion criteria include but are not limited to the following:&#xD;
&#xD;
        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 on androgen deprivation therapy (or post&#xD;
             bilateral orchiectomy) within 6 months prior to screening&#xD;
&#xD;
          -  Has current evidence of metastatic disease documented by either bone lesions on bone&#xD;
             scan and/or soft tissue disease by computed tomography/magnetic resonance imaging&#xD;
             (CT/MRI)&#xD;
&#xD;
          -  Has received prior treatment with one (but not more than one) NHA (eg, abiraterone&#xD;
             acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive&#xD;
             prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a)&#xD;
             progressed through treatment OR b) has become intolerant of the drug&#xD;
&#xD;
          -  Has ongoing androgen deprivation with serum testosterone &lt;50 ng/dL (&lt;2.0 nM)&#xD;
&#xD;
          -  Participants receiving bone resorptive therapy (including, but not limited to,&#xD;
             bisphosphonate or denosumab) must have been on stable doses prior to randomization&#xD;
&#xD;
          -  Participants must agree to the following during the study treatment period and for at&#xD;
             least 120 days after the last dose of pembrolizumab or for at least 180 days after the&#xD;
             last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use&#xD;
             contraception unless confirmed to be azoospermic (vasectomized or secondary to medical&#xD;
             cause)&#xD;
&#xD;
          -  Participants must agree to use male condom when engaging in any activity that allows&#xD;
             for passage of ejaculate to another person of any sex&#xD;
&#xD;
          -  Has provided newly obtained core or excisional biopsy (obtained within 12 months of&#xD;
             screening) from soft tissue not previously irradiated (samples from tumors progressing&#xD;
             in a prior site of radiation are allowed). Participants with bone only or bone&#xD;
             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 past 2 years&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy&#xD;
&#xD;
          -  Has undergone major surgery including local prostate intervention (excluding prostate&#xD;
             biopsy) within 28 days prior to randomization and not recovered adequately from the&#xD;
             toxicities and/or complications&#xD;
&#xD;
          -  Has a gastrointestinal disorder affecting absorption or is unable to swallow&#xD;
             tablets/capsules&#xD;
&#xD;
          -  Has an active infection (including tuberculosis) requiring systemic therapy&#xD;
&#xD;
          -  Has a history of (non-infectious) pneumonitis that required steroids or current&#xD;
             pneumonitis&#xD;
&#xD;
          -  Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or&#xD;
             hepatitis C virus (HCV) infection&#xD;
&#xD;
          -  Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis&#xD;
&#xD;
          -  Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients&#xD;
&#xD;
          -  Has symptomatic congestive heart failure (New York Heart Association Class III or IV&#xD;
             heart disease)&#xD;
&#xD;
          -  Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who&#xD;
             has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs&#xD;
&#xD;
          -  Has used herbal products that may have hormonal anti-prostate cancer activity and/or&#xD;
             are known to decrease PSA levels (e.g. saw palmetto) prior to randomization&#xD;
&#xD;
          -  Has received prior treatment with radium or other therapeutic radiopharmaceuticals for&#xD;
             prostate cancer&#xD;
&#xD;
          -  Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1),&#xD;
             anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent&#xD;
             directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic&#xD;
             T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)&#xD;
&#xD;
          -  Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC&#xD;
&#xD;
          -  Has hypersensitivity to docetaxel or polysorbate 80&#xD;
&#xD;
          -  Is currently receiving either strong or moderate inhibitors of cytochrome P450&#xD;
             (CYP)3A4 that cannot be discontinued for the duration of the study&#xD;
&#xD;
          -  Has received prior targeted small molecule therapy or abiraterone acetate,&#xD;
             enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of&#xD;
             study treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to&#xD;
             a previously administered agent&#xD;
&#xD;
          -  Has received prior radiotherapy to within 2 weeks of start of study treatment.&#xD;
             Participants must have recovered from all radiation-related toxicities, not require&#xD;
             corticosteroids, and not have had radiation pneumonitis&#xD;
&#xD;
          -  Has received a live vaccine within 30 days prior to randomization&#xD;
&#xD;
          -  Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride),&#xD;
             estrogens, and/or cyproterone within 4 weeks prior to randomization&#xD;
&#xD;
          -  Has received prior treatment with ketoconazole for prostate cancer&#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 prior to the first dose of&#xD;
             study treatment&#xD;
&#xD;
          -  Has a &quot;superscan&quot; bone scan&#xD;
&#xD;
          -  Is expecting to conceive or father children within the projected duration of the&#xD;
             study, starting with the screening visit through 120 days after the last dose of study&#xD;
             treatment&#xD;
&#xD;
          -  Has had an allogenic tissue/solid organ transplant&#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>University of South Alabama, Mitchell Cancer Institute ( Site 0065)</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>University of Southern California Norris Comprehensive Cancer Center ( Site 0061)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC Norris Oncology Hematology Newport Beach ( Site 0093)</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco ( Site 0023)</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center ( Site 0022)</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale Cancer Center ( Site 0038)</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center ( Site 0080)</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</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>Mount Sinai Hospital Medical Center ( Site 0042)</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital- Merriillville ( Site 0008)</name>
      <address>
        <city>Merrillville</city>
        <state>Indiana</state>
        <zip>46410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>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>48202-2608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer &amp; Hematology Centers of Western Michigan ( Site 0013)</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine ( Site 0057)</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</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>John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</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 ( Site 0010)</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>W. G. Bill Hefner VA Medical Center ( Site 0029)</name>
      <address>
        <city>Salisbury</city>
        <state>North Carolina</state>
        <zip>28144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center ( Site 0036)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health Sciences University ( Site 0031)</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</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>Inova Schar Cancer Institute ( Site 0006)</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031-4867</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>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>Instituto de Investigaciones Clinicas ( Site 1000)</name>
      <address>
        <city>Mar del Plata</city>
        <state>Buenos Aires</state>
        <zip>B7600FZN</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 [Buenos Aires, Argentina] ( 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 George Hospital ( Site 0157)</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</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>Redcliffe Hospital ( Site 0161)</name>
      <address>
        <city>Redcliffe</city>
        <state>Queensland</state>
        <zip>4020</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>Hollywood Private Hospital ( Site 0163)</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</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>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>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>Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand River Hospital ( Site 0120)</name>
      <address>
        <city>Kitchener</city>
        <state>Ontario</state>
        <zip>N2G 1G3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeridge Health ( Site 0117)</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Research Institute ( Site 0108)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</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>CHU de Quebec-Universite 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>Centro de Investigaciones Clinicas Vina del Mar ( Site 1042)</name>
      <address>
        <city>Vina del Mar</city>
        <state>Valparaiso</state>
        <zip>2540488</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University First Hospital ( Site 1303)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fifth Medical Center of PLA General Hospital ( Site 1307)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital ( Site 1305)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xiamen University ( Site 1319)</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat Sen Memorial Hospital ( Site 1323)</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510220</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University ( Site 1330)</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510230</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital ( Site 1326)</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital ( Site 1321)</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital ( Site 1329)</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital ( Site 1320)</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital ( Site 1312)</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center ( Site 1300)</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University ( Site 1301)</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309)</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Provincial People's Hospital ( Site 1310)</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Tobon Uribe ( Site 1066)</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>050034</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biomelab S A S ( Site 1067)</name>
      <address>
        <city>Barranquilla</city>
        <state>Atlantico</state>
        <zip>080002</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de la Costa Ltda. ( Site 1073)</name>
      <address>
        <city>Barranquilla</city>
        <state>Atlantico</state>
        <zip>080020</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)</name>
      <address>
        <city>Valledupar</city>
        <state>Cesar</state>
        <zip>200001</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncomedica S.A. ( Site 1057)</name>
      <address>
        <city>Monteria</city>
        <state>Cordoba</state>
        <zip>230002</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Cancerologia E.S.E ( Site 1061)</name>
      <address>
        <city>Bogota</city>
        <state>Distrito Capital De Bogota</state>
        <zip>110321</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)</name>
      <address>
        <city>Bogota</city>
        <state>Distrito Capital De Bogota</state>
        <zip>111321</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncologos del Occidente S.A. ( Site 1072)</name>
      <address>
        <city>Pereira</city>
        <state>Risaralda</state>
        <zip>660001</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Imbanaco de Cali S.A ( Site 1064)</name>
      <address>
        <city>Cali</city>
        <state>Valle Del Cauca</state>
        <zip>760042</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hemato Oncologos S.A. ( Site 1065)</name>
      <address>
        <city>Cali</city>
        <state>Valle Del Cauca</state>
        <zip>760042</zip>
        <country>Colombia</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>Centre Leon Berard ( Site 0422)</name>
      <address>
        <city>Lyon</city>
        <state>Auvergne</state>
        <zip>69373</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 Jean Minjoz ( Site 0423)</name>
      <address>
        <city>Besancon</city>
        <state>Doubs</state>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Brest -Site Hopital Morvan ( Site 0441)</name>
      <address>
        <city>Brest</city>
        <state>Finistere</state>
        <zip>29200</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>92151</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>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>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 Wuerzburg ( Site 0302)</name>
      <address>
        <city>Wuerzburg</city>
        <state>Bayern</state>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Goettingen ( Site 0345)</name>
      <address>
        <city>Goettingen</city>
        <state>Niedersachsen</state>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik RWTH Aachen ( Site 0308)</name>
      <address>
        <city>Aachen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum des Saarlandes ( Site 0348)</name>
      <address>
        <city>Homburg</city>
        <state>Saarland</state>
        <zip>66421</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>Charite Universitaetsmedizin Berlin ( Site 0301)</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cork University Hospital ( Site 0727)</name>
      <address>
        <city>Cork</city>
        <zip>T12 YE02</zip>
        <country>Ireland</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>Soroka Medical Center ( Site 0548)</name>
      <address>
        <city>Beer Sheva</city>
        <zip>8410101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh MC ( Site 0547)</name>
      <address>
        <city>Beer Yaakov-Zerifin</city>
        <zip>7030001</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 Clinico Humanitas Research Hospital ( Site 0452)</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</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>A.O. Universitaria di Modena ( Site 0454)</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457)</name>
      <address>
        <city>Napoli</city>
        <zip>80131</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>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>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>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>1932</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>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>Nagasaki University Hospital ( Site 0719)</name>
      <address>
        <city>Nagasaki</city>
        <zip>852-8501</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>National Cancer Center ( Site 0174)</name>
      <address>
        <city>Goyang-si</city>
        <state>Kyonggi-do</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital ( Site 0175)</name>
      <address>
        <city>Seongnam-si</city>
        <state>Kyonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital ( Site 0171)</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center ( Site 0176)</name>
      <address>
        <city>Seoul</city>
        <zip>05505</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>Ziekenhuis Gelderse Vallei ( Site 0485)</name>
      <address>
        <city>Ede</city>
        <state>Gelderland</state>
        <zip>6746 RP</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>VieCuri Medisch Centrum ( Site 0487)</name>
      <address>
        <city>Venlo</city>
        <state>Limburg</state>
        <zip>5912 BL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeroen Bosch Ziekenhuis ( Site 1200)</name>
      <address>
        <city>Den Bosch</city>
        <state>Noord-Brabant</state>
        <zip>5223 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis ( Site 0472)</name>
      <address>
        <city>Eindhoven</city>
        <state>Noord-Brabant</state>
        <zip>5623 EJ</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>Ziekenhuis Hilversum ( Site 0466)</name>
      <address>
        <city>Hilversum</city>
        <state>Noord-Holland</state>
        <zip>1213 XZ</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>Reinier de Graaf Groep ( Site 0484)</name>
      <address>
        <city>Delft</city>
        <state>Zuid-Holland</state>
        <zip>2625 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hagaziekenhuis ( Site 1201)</name>
      <address>
        <city>Den Haag</city>
        <state>Zuid-Holland</state>
        <zip>2545 AA</zip>
        <country>Netherlands</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>SBIH City clinical hospital named after D.D. Pletniov ( Site 0575)</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>105077</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Scientific Center of Radiology ( Site 0559)</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>117485</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>National Medical Research Radiological Center ( Site 0556)</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Volga District Medical Center Federal Medical and Biological Agency ( Site 0572)</name>
      <address>
        <city>Nizhny Novgorod</city>
        <state>Nizhegorodskaya Oblast</state>
        <zip>603074</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>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>SPb SBHI City Clinical Oncological Dispensary ( Site 0571)</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>198255</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leningrad Regional Oncology Center ( Site 0588)</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>188663</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0579)</name>
      <address>
        <city>Tomsk</city>
        <state>Tomskaya Oblast</state>
        <zip>634050</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 Consorci Sanitari 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 Universitario Marques de Valdecilla ( Site 0336)</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</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 del Mar ( Site 0333)</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</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 Ramon y Cajal ( Site 0328)</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos ( Site 0324)</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro ( Site 0322)</name>
      <address>
        <city>Madrid</city>
        <zip>28050</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>Hospital Virgen del Rocio ( Site 0329)</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</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>40705</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>Weston Park Hospital ( Site 0539)</name>
      <address>
        <city>Sheffield</city>
        <state>England</state>
        <zip>S10 2SJ</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>Mount Vernon Cancer Centre ( Site 0536)</name>
      <address>
        <city>Northwood</city>
        <state>Hertfordshire</state>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts Cancer Institute ( Site 0483)</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>EC1A 7BE</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_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>China</country>
    <country>Colombia</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>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://merckclinicaltrials.com/</url>
    <description>Merck Clinical Trials Information</description>
  </link>
  <verification_date>August 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>May 23, 2023</results_first_submitted>
  <results_first_submitted_qc>May 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 18, 2023</results_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Programmed Cell Death 1 (PD 1, PD-1)</keyword>
  <keyword>Programmed Cell Death 1 Ligand 1 (PDL 1, PD-L1)</keyword>
  <keyword>Programmed Cell Death 1 Ligand 2 (PDL 2, 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>Dexamethasone</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Pembrolizumab</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>September 29, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT03834506/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of the 1030 participants randomized in the MK-3475-921 global study, 21 participants were also included in the China extension study for MK-3475-921 (NCT04907227).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pembrolizumab + Docetaxel</title>
          <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
        </group>
        <group group_id="P2">
          <title>Placebo + Docetaxel</title>
          <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="515"/>
                <participants group_id="P2" count="515"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="514"/>
                <participants group_id="P2" count="514"/>
              </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="515"/>
                <participants group_id="P2" count="515"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="268"/>
                <participants group_id="P2" count="285"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Parent/Guardian</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participants ongoing in the study</title>
              <participants_list>
                <participants group_id="P1" count="234"/>
                <participants group_id="P2" count="221"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis population consisted of all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Pembrolizumab + Docetaxel</title>
          <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
        </group>
        <group group_id="B2">
          <title>Placebo + Docetaxel</title>
          <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</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="515"/>
            <count group_id="B2" value="515"/>
            <count group_id="B3" value="1030"/>
          </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="7.9"/>
                    <measurement group_id="B2" value="70.4" spread="7.1"/>
                    <measurement group_id="B3" value="70.1" spread="7.5"/>
                  </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="515"/>
                    <measurement group_id="B2" value="515"/>
                    <measurement group_id="B3" value="1030"/>
                  </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="79"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="402"/>
                    <measurement group_id="B2" value="393"/>
                    <measurement group_id="B3" value="795"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="79"/>
                  </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="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="154"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="401"/>
                    <measurement group_id="B2" value="399"/>
                    <measurement group_id="B3" value="800"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Treatment with a Next Generation Hormonal Agent (NHA): Abiraterone Acetate</title>
          <description>Participants were stratified according to prior treatment with abiraterone acetate. Participants were eligible for the study if they had received prior treatment with a NHA (abiraterone acetate) for metastatic hormone-sensitive prostate cancer (mHSPC) or metastatic castration-resistant prostate cancer (CRPC) and either progressed after treatment or became intolerant of the drug.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="278"/>
                    <measurement group_id="B2" value="277"/>
                    <measurement group_id="B3" value="555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="237"/>
                    <measurement group_id="B2" value="238"/>
                    <measurement group_id="B3" value="475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Metastases at Baseline</title>
          <description>Participants were stratified by the type of metastases present at baseline determined by blinded independent central review. If the metastases were only in the bone the participants were categorized as bone only. If the metastases were not in the bone, but in the liver, participants were categorized as liver. All other participants were categorized as other.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Bone only</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="268"/>
                    <measurement group_id="B2" value="239"/>
                    <measurement group_id="B3" value="507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Liver</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="213"/>
                    <measurement group_id="B2" value="243"/>
                    <measurement group_id="B3" value="456"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)</title>
          <description>Participants were classified by ECOG PS defined as:&#xD;
ECOG=0: Fully active, able to carry out all pre-disease performance with no restriction; ECOG=1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; ECOG=2: Ambulatory and capable of all self-care but unable to carry out work activities, up and about &gt;50% of waking hours; ECOG=3: Capable of only limited self-care, confined to bed or chair &gt;50% of waking hours; ECOG=4: Completely disabled, cannot carry out self-care, totally confined to bed or chair; ECOG=5: Dead</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>ECOG = 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="298"/>
                    <measurement group_id="B2" value="286"/>
                    <measurement group_id="B3" value="584"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG = 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="212"/>
                    <measurement group_id="B2" value="227"/>
                    <measurement group_id="B3" value="439"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG = 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG = 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG = 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG = 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.</description>
        <time_frame>Up to 36.5 months</time_frame>
        <population>All randomized participants in the intent to treat population who had data available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.</description>
          <population>All randomized participants in the intent to treat population who had data available for analysis</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="515"/>
                <count group_id="O2" value="515"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.6" lower_limit="18.2" upper_limit="20.9"/>
                    <measurement group_id="O2" value="19.0" lower_limit="17.9" upper_limit="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1677</p_value>
            <p_value_desc>One-sided p-value based on log-rank test stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases by baseline.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
            <estimate_desc>HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases by baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)</title>
        <description>rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.</description>
        <time_frame>Up to approximately 28 months</time_frame>
        <population>All randomized participants in the intent to treat population who had data available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)</title>
          <description>rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.</description>
          <population>All randomized participants in the intent to treat population who had data available for analysis</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="515"/>
                <count group_id="O2" value="515"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" lower_limit="8.3" upper_limit="10.2"/>
                    <measurement group_id="O2" value="8.3" lower_limit="8.2" upper_limit="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0335</p_value>
            <p_value_desc>One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
            <estimate_desc>HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)</title>
        <description>TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit (Kaplan-Meier) method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received.</description>
        <time_frame>Up to approximately 28 months</time_frame>
        <population>All randomized participants in the intent to treat population who had data available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)</title>
          <description>TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit (Kaplan-Meier) method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received.</description>
          <population>All randomized participants in the intent to treat population who had data available for analysis</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="515"/>
                <count group_id="O2" value="515"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" lower_limit="10.4" upper_limit="11.1"/>
                    <measurement group_id="O2" value="10.4" lower_limit="9.7" upper_limit="11.1"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0331</p_value>
            <p_value_desc>One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
            <estimate_desc>HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prostate-specific Antigen (PSA) Response Rate</title>
        <description>The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements.</description>
        <time_frame>Up to 36.5 months</time_frame>
        <population>All randomized participants in the intent to treat population, who had a PSA measurement at baseline, and had data available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Prostate-specific Antigen (PSA) Response Rate</title>
          <description>The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements.</description>
          <population>All randomized participants in the intent to treat population, who had a PSA measurement at baseline, and had data available for analysis</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="474"/>
                <count group_id="O2" value="486"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.5" lower_limit="40.0" upper_limit="49.1"/>
                    <measurement group_id="O2" value="45.7" lower_limit="41.2" upper_limit="50.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review</title>
        <description>ORR was 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) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).</description>
        <time_frame>Up to 36.5 months</time_frame>
        <population>All randomized participants in the intent to treat population, with measurable disease at baseline, and had data available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review</title>
          <description>ORR was 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) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).</description>
          <population>All randomized participants in the intent to treat population, with measurable disease at baseline, and had data available for analysis</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="203"/>
                <count group_id="O2" value="221"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.5" lower_limit="27.0" upper_limit="40.4"/>
                    <measurement group_id="O2" value="35.3" lower_limit="29.0" upper_limit="42.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6545</p_value>
            <p_value_desc>Based on Miettinen &amp; Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases by baseline.</p_value_desc>
            <method>Miettinen &amp; Nurminen method</method>
            <param_type>Percent Difference</param_type>
            <param_value>-1.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.7</ci_lower_limit>
            <ci_upper_limit>7.1</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases by baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review</title>
        <description>DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was 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. PD per PCWG was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for ≥6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.</description>
        <time_frame>Up to 36.5 months</time_frame>
        <population>All randomized participants in the intent to treat population, who demonstrated a CR or PR, and had data available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review</title>
          <description>DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was 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. PD per PCWG was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for ≥6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.</description>
          <population>All randomized participants in the intent to treat population, who demonstrated a CR or PR, and had data available for analysis</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="68"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="6.1" upper_limit="7.8"/>
                    <measurement group_id="O2" value="6.2" lower_limit="6.2" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (&quot;Worst Pain in 24 Hours&quot;) and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score</title>
        <description>TTPP was defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF and by the AQA score. Pain progression was defined as:&#xD;
For participants 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 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;
TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had &gt; 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.</description>
        <time_frame>Up to 36.5 months</time_frame>
        <population>All participants in the patient-reported outcomes (PRO) full analysis set who received ≥1 dose of study treatment and who had ≥1 PRO assessment available</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 (&quot;Worst Pain in 24 Hours&quot;) and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score</title>
          <description>TTPP was defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF and by the AQA score. Pain progression was defined as:&#xD;
For participants 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 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;
TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had &gt; 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.</description>
          <population>All participants in the patient-reported outcomes (PRO) full analysis set who received ≥1 dose of study treatment and who had ≥1 PRO assessment available</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="507"/>
                <count group_id="O2" value="502"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" lower_limit="13.7" upper_limit="NA">NA= Upper limit not reached at time of data cut off due to insufficient number of participants with an event.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="13.8" upper_limit="NA">NA= Median and upper limit not reached at time of data cut off due to insufficient number of participants with an event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6178</p_value>
            <method>Log Rank</method>
            <method_desc>One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.05</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>1.43</ci_upper_limit>
            <estimate_desc>HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Symptomatic Skeletal-related Event (SSRE)</title>
        <description>SSRE was the time from randomization to the first symptomatic skeletal-related event defined as:&#xD;
Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms&#xD;
Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral)&#xD;
Occurrence of spinal cord compression&#xD;
Tumor-related orthopedic surgical intervention, whichever occurs first.&#xD;
The SSRE was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.</description>
        <time_frame>Up to 36.5 months</time_frame>
        <population>All randomized participants in the intent to treat population who had data available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Symptomatic Skeletal-related Event (SSRE)</title>
          <description>SSRE was the time from randomization to the first symptomatic skeletal-related event defined as:&#xD;
Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms&#xD;
Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral)&#xD;
Occurrence of spinal cord compression&#xD;
Tumor-related orthopedic surgical intervention, whichever occurs first.&#xD;
The SSRE was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.</description>
          <population>All randomized participants in the intent to treat population who had data available for analysis</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="515"/>
                <count group_id="O2" value="515"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA=Median and lower and upper limits not reached at time of data cut off due to insufficient number of participants with an event.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA=Median and lower and upper limits not reached at time of data cut off due to insufficient number of participants with an event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9788</p_value>
            <method>Log Rank</method>
            <method_desc>One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>2.33</ci_upper_limit>
            <estimate_desc>HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Prostate-specific Antigen (PSA) Progression</title>
        <description>The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of:&#xD;
≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR&#xD;
≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline&#xD;
Time to PSA progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment.</description>
        <time_frame>Up to 36.5 months</time_frame>
        <population>All randomized participants in the intent to treat population, who had a PSA measurement at baseline, and had data available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Prostate-specific Antigen (PSA) Progression</title>
          <description>The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of:&#xD;
≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR&#xD;
≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline&#xD;
Time to PSA progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment.</description>
          <population>All randomized participants in the intent to treat population, who had a PSA measurement at baseline, and had data available for analysis</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="515"/>
                <count group_id="O2" value="515"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="6.2" upper_limit="7.6"/>
                    <measurement group_id="O2" value="7.0" lower_limit="6.3" upper_limit="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2970</p_value>
            <method>Log Rank</method>
            <method_desc>One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.96</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>1.12</ci_upper_limit>
            <estimate_desc>HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)</title>
        <description>The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was 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 was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.</description>
        <time_frame>Up to 36.5 months</time_frame>
        <population>All randomized participants in the intent to treat population who had data available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)</title>
          <description>The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was 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 was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.</description>
          <population>All randomized participants in the intent to treat population who had data available for analysis</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="515"/>
                <count group_id="O2" value="515"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.4" lower_limit="10.7" upper_limit="14.9"/>
                    <measurement group_id="O2" value="11.2" lower_limit="10.4" upper_limit="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2876</p_value>
            <method>Log Rank</method>
            <method_desc>One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
            <estimate_desc>HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases by baseline.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced an Adverse Event (AE)</title>
        <description>An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.</description>
        <time_frame>Up to approximately 30 months</time_frame>
        <population>All participants who received ≥1 dose of study treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced an Adverse Event (AE)</title>
          <description>An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.</description>
          <population>All participants who received ≥1 dose of study treatment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="514"/>
                <count group_id="O2" value="514"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="508"/>
                    <measurement group_id="O2" value="505"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)</title>
        <description>An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.</description>
        <time_frame>Up to approximately 27 months</time_frame>
        <population>All participants who received ≥1 dose of study treatment</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Docetaxel</title>
            <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)</title>
          <description>An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.</description>
          <population>All participants who received ≥1 dose of study treatment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="514"/>
                <count group_id="O2" value="514"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150"/>
                    <measurement group_id="O2" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events=up to approximately 30 months All-cause mortality=up to 36.5 months</time_frame>
      <desc>All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pembrolizumab + Docetaxel</title>
          <description>Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
        </group>
        <group group_id="E2">
          <title>Placebo + Docetaxel</title>
          <description>Participants received placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also received dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="275" subjects_at_risk="515"/>
                <counts group_id="E2" subjects_affected="288" subjects_at_risk="515"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="211" subjects_at_risk="514"/>
                <counts group_id="E2" subjects_affected="196" subjects_at_risk="514"/>
              </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="5" subjects_affected="5" subjects_at_risk="514"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Febrile bone marrow aplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="34" subjects_affected="28" subjects_at_risk="514"/>
                <counts group_id="E2" events="23" subjects_affected="22" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Immune thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Necrotic lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="514"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cardiac ventricular thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Stress cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Subendocardial ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness unilateral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Retinal artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Retinal tear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="514"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Immune-mediated enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Intestinal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Neutropenic colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Oroantral fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Proctitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Small intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </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="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Complication associated with device</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="514"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Contrast media allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Haemophagocytic lymphohistiocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Abscess neck</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="514"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="514"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Catheter site cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Clostridial sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Device related bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Endophthalmitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Enterocolitis infectious</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Herpes zoster meningomyelitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Joint abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Meningitis meningococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Meningoencephalitis herpetic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Oropharyngeal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Parotitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pleural infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="514"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pneumonia influenzal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pseudomembranous colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Spinal cord infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="514"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Urinary tract infection staphylococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Vascular device infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Vestibular neuronitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cystitis radiation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Fracture displacement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Patella fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pulmonary radiation injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Radiation proctitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Sternal fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Transfusion related complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Vascular access complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Blood calcium increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hypervolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </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="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="514"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="514"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Crowned dens syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Spinal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma gastric</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Metastases to meninges</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Neuroendocrine carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pituitary tumour benign</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Skin cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Small cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Tumour compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cauda equina syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cerebellar haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Myasthenia gravis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </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="6" subjects_affected="6" subjects_at_risk="514"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Calculus bladder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="514"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Oedema genital</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Immune-mediated lung disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Obstructive airways disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="514"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="514"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pulmonary toxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Stevens-Johnson syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Femoral artery aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="514"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Jugular vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="514"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 25.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="493" subjects_at_risk="514"/>
                <counts group_id="E2" subjects_affected="488" subjects_at_risk="514"/>
              </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="174" subjects_affected="145" subjects_at_risk="514"/>
                <counts group_id="E2" events="166" subjects_affected="124" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="52" subjects_affected="41" subjects_at_risk="514"/>
                <counts group_id="E2" events="46" subjects_affected="37" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="35" subjects_affected="33" subjects_at_risk="514"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" events="35" subjects_affected="33" subjects_at_risk="514"/>
                <counts group_id="E2" events="38" subjects_affected="38" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="30" subjects_affected="26" subjects_at_risk="514"/>
                <counts group_id="E2" events="32" subjects_affected="28" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="152" subjects_affected="110" subjects_at_risk="514"/>
                <counts group_id="E2" events="98" subjects_affected="84" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="353" subjects_affected="206" subjects_at_risk="514"/>
                <counts group_id="E2" events="289" subjects_affected="184" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="175" subjects_affected="122" subjects_at_risk="514"/>
                <counts group_id="E2" events="193" subjects_affected="135" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="42" subjects_affected="33" subjects_at_risk="514"/>
                <counts group_id="E2" events="30" subjects_affected="29" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="69" subjects_affected="49" subjects_at_risk="514"/>
                <counts group_id="E2" events="89" subjects_affected="69" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="179" subjects_affected="131" subjects_at_risk="514"/>
                <counts group_id="E2" events="200" subjects_affected="127" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="255" subjects_affected="183" subjects_at_risk="514"/>
                <counts group_id="E2" events="223" subjects_affected="184" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="30" subjects_affected="26" subjects_at_risk="514"/>
                <counts group_id="E2" events="34" subjects_affected="31" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="105" subjects_affected="95" subjects_at_risk="514"/>
                <counts group_id="E2" events="118" subjects_affected="104" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="69" subjects_affected="58" subjects_at_risk="514"/>
                <counts group_id="E2" events="51" subjects_affected="41" subjects_at_risk="514"/>
              </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="48" subjects_affected="36" subjects_at_risk="514"/>
                <counts group_id="E2" events="38" subjects_affected="33" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="38" subjects_affected="27" subjects_at_risk="514"/>
                <counts group_id="E2" events="30" subjects_affected="28" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="32" subjects_affected="29" subjects_at_risk="514"/>
                <counts group_id="E2" events="27" subjects_affected="24" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="28" subjects_affected="28" subjects_at_risk="514"/>
                <counts group_id="E2" events="26" subjects_affected="25" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="106" subjects_affected="46" subjects_at_risk="514"/>
                <counts group_id="E2" events="111" subjects_affected="49" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="44" subjects_affected="41" subjects_at_risk="514"/>
                <counts group_id="E2" events="29" subjects_affected="29" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="60" subjects_affected="32" subjects_at_risk="514"/>
                <counts group_id="E2" events="54" subjects_affected="27" subjects_at_risk="514"/>
              </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="142" subjects_affected="105" subjects_at_risk="514"/>
                <counts group_id="E2" events="126" subjects_affected="98" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="53" subjects_affected="46" subjects_at_risk="514"/>
                <counts group_id="E2" events="65" subjects_affected="52" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="37" subjects_affected="27" subjects_at_risk="514"/>
                <counts group_id="E2" events="19" subjects_affected="14" subjects_at_risk="514"/>
              </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="116" subjects_affected="83" subjects_at_risk="514"/>
                <counts group_id="E2" events="118" subjects_affected="96" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="104" subjects_affected="91" subjects_at_risk="514"/>
                <counts group_id="E2" events="116" subjects_affected="100" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="45" subjects_affected="42" subjects_at_risk="514"/>
                <counts group_id="E2" events="51" subjects_affected="45" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="54" subjects_affected="48" subjects_at_risk="514"/>
                <counts group_id="E2" events="50" subjects_affected="42" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="45" subjects_affected="39" subjects_at_risk="514"/>
                <counts group_id="E2" events="58" subjects_affected="46" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="41" subjects_affected="38" subjects_at_risk="514"/>
                <counts group_id="E2" events="49" subjects_affected="41" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="87" subjects_affected="72" subjects_at_risk="514"/>
                <counts group_id="E2" events="84" subjects_affected="78" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="49" subjects_affected="38" subjects_at_risk="514"/>
                <counts group_id="E2" events="39" subjects_affected="34" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="28" subjects_affected="27" subjects_at_risk="514"/>
                <counts group_id="E2" events="30" subjects_affected="27" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="143" subjects_affected="132" subjects_at_risk="514"/>
                <counts group_id="E2" events="108" subjects_affected="100" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="50" subjects_affected="42" subjects_at_risk="514"/>
                <counts group_id="E2" events="46" subjects_affected="46" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="25" subjects_affected="23" subjects_at_risk="514"/>
                <counts group_id="E2" events="32" subjects_affected="28" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="51" subjects_affected="46" subjects_at_risk="514"/>
                <counts group_id="E2" events="39" subjects_affected="36" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="65" subjects_affected="60" subjects_at_risk="514"/>
                <counts group_id="E2" events="63" subjects_affected="59" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="185" subjects_affected="182" subjects_at_risk="514"/>
                <counts group_id="E2" events="198" subjects_affected="193" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="24" subjects_affected="23" subjects_at_risk="514"/>
                <counts group_id="E2" events="32" subjects_affected="29" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Nail discolouration</sub_title>
                <counts group_id="E1" events="26" subjects_affected="25" subjects_at_risk="514"/>
                <counts group_id="E2" events="28" subjects_affected="27" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Nail disorder</sub_title>
                <counts group_id="E1" events="29" subjects_affected="29" subjects_at_risk="514"/>
                <counts group_id="E2" events="29" subjects_affected="29" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="53" subjects_affected="46" subjects_at_risk="514"/>
                <counts group_id="E2" events="31" subjects_affected="26" subjects_at_risk="514"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="69" subjects_affected="57" subjects_at_risk="514"/>
                <counts group_id="E2" events="62" subjects_affected="54" subjects_at_risk="514"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="31" subjects_affected="28" subjects_at_risk="514"/>
                <counts group_id="E2" events="31" subjects_affected="28" subjects_at_risk="514"/>
              </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/NCT03834506
org study id: 3475-921
secondary id: MK-3475-921
secondary id: KEYNOTE-921
secondary id: JAPAC-CTI
secondary id: 2018-004116-22
nct id: NCT03834506
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
      pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic
      castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but
      have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).

      There are two primary study hypotheses.

      Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to
      placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).

      Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to
      placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival
      (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in
      Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.
With Amendment 6 (effective date: 29-Sep-2022), all participants will be unblinded and
      placebo treatment will be stopping. Participants who are deemed to be deriving clinical
      benefit from treatment may continue at the discretion of the investigator.

      The global study for MK-3475-921 enrolled 1030 participants. Of the 1030 total participants
      enrolled in the global study, 21 were also enrolled in the China extension study for
      MK-3475-921 (NCT04907227).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Overall Survival (OS)
time frame: Up to 36.5 months
description: OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
measure: Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
time frame: Up to approximately 28 months
description: rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per RECIST 1.1 was ≥20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for ≥6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.
measure: Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
time frame: Up to approximately 28 months
description: TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit (Kaplan-Meier) method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received.
measure: Prostate-specific Antigen (PSA) Response Rate
time frame: Up to 36.5 months
description: The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements.
measure: Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
time frame: Up to 36.5 months
description: ORR was 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) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).
measure: Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
time frame: Up to 36.5 months
description: DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was 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. PD per PCWG was the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for ≥6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.
measure: Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score
time frame: Up to 36.5 months
description: TTPP was defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF and by the AQA score. Pain progression was defined as:
For participants 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 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.
TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had > 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.
measure: Time to First Symptomatic Skeletal-related Event (SSRE)
time frame: Up to 36.5 months
description: SSRE was the time from randomization to the first symptomatic skeletal-related event defined as:
Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms
Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral)
Occurrence of spinal cord compression
Tumor-related orthopedic surgical intervention, whichever occurs first.
The SSRE was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.
measure: Time to Prostate-specific Antigen (PSA) Progression
time frame: Up to 36.5 months
description: The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of:
≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR
≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline
Time to PSA progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment.
measure: Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
time frame: Up to 36.5 months
description: The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was 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 was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.
measure: Number of Participants Who Experienced an Adverse Event (AE)
time frame: Up to approximately 30 months
description: An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.
measure: Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
time frame: Up to approximately 27 months
description: An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.
arm group label: Pembrolizumab+Docetaxel
arm group type: Experimental
description: Participants receive pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.
arm group label: Placebo+Docetaxel
arm group type: Placebo Comparator
description: Participants receive placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.
intervention type: Biological
intervention name: Pembrolizumab
description: IV infusion
arm group label: Pembrolizumab+Docetaxel
other name: MK-3475
other name: KEYTRUDA®
intervention type: Drug
intervention name: Docetaxel
description: IV infusion
arm group label: Pembrolizumab+Docetaxel
arm group label: Placebo+Docetaxel
other name: TAXOTERE®
intervention type: Drug
intervention name: Prednisone
description: Oral tablets
arm group label: Pembrolizumab+Docetaxel
arm group label: Placebo+Docetaxel
intervention type: Drug
intervention name: Placebo
description: IV infusion
arm group label: Placebo+Docetaxel
other name: Normal saline or dextrose infusion
intervention type: Drug
intervention name: Dexamethasone
description: Oral tablets
arm group label: Pembrolizumab+Docetaxel
arm group label: Placebo+Docetaxel
other name: DECADRON®
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: China
country: Colombia
country: France
country: Germany
country: Ireland
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: Russian Federation
country: Spain
country: Taiwan
country: United Kingdom
country: United States
url: http://merckclinicaltrials.com/
description: Merck Clinical Trials Information
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Dexamethasone
mesh term: Prednisone
mesh term: Docetaxel
mesh term: Pembrolizumab
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: 