<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/NCT01715285</url>
  </required_header>
  <id_info>
    <org_study_id>CR100900</org_study_id>
    <secondary_id>212082PCR3011</secondary_id>
    <secondary_id>2012-002940-26</secondary_id>
    <secondary_id>U1111-1135-7146</secondary_id>
    <nct_id>NCT01715285</nct_id>
  </id_info>
  <brief_title>A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)</brief_title>
  <official_title>A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if newly diagnosed (within previous 3 months)&#xD;
      participants with metastatic (spread of cancer cells from one part of the body to another )&#xD;
      hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from&#xD;
      the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy&#xD;
      (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (the treatment group is assigned by chance), double-blind (neither&#xD;
      physician nor participant knows the treatment that the participant receives), placebo (an&#xD;
      inactive substance that is compared with a drug to test whether the drug has a real effect in&#xD;
      a clinical trial)-controlled study designed to determine the efficacy of abiraterone acetate&#xD;
      plus low-dose prednisone in participants with mHNPC. The study consists of 4 parts: Screening&#xD;
      Phase (that is, 28 days before study commences on Day 1); Double-blind treatment Phase&#xD;
      (consists of 4-week dosing cycles wherein abiraterone acetate will be administered as 1,000&#xD;
      milligram [mg] plus 5 mg prednisone or only placebo orally); Follow-up Phase (every 4 months&#xD;
      up to 60 months or until death, lost to follow up, withdrawal of consent or study&#xD;
      termination) Open-label Extension (OLE) Phase. Participants in the Double-blind Treatment&#xD;
      Phase will have the opportunity to enroll into the OLE Phase. The OLE Phase will allow&#xD;
      participants to receive active drug (abiraterone acetate plus prednisone) until Long-term&#xD;
      Extension (LTE) Phase for an additional period of up to 3 years. Participants will&#xD;
      discontinue study treatment at disease progression or unacceptable toxicity unless, in the&#xD;
      Investigator's opinion, it is deemed that the participants will continue to derive benefit&#xD;
      from study treatment. Participants will be randomized in a 1:1 ratio to the active treatment&#xD;
      group (abiraterone acetate 1000 mg daily plus prednisone 5 mg daily plus ADT) or the control&#xD;
      group (ADT plus placebos).Efficacy will be evaluated primarily by overall survival and&#xD;
      radiographic progression-free survival. Participants' safety will be monitored throughout the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2013</start_date>
  <completion_date type="Actual">February 13, 2022</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiographic Progression-Free Survival (PFS)</measure>
    <time_frame>Up to 44 months</time_frame>
    <description>Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 [PCWG2] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 66 months</time_frame>
    <description>Overall survival was defined as the time from randomization to date of death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Initiation of Chemotherapy</measure>
    <time_frame>Up to 66 months</time_frame>
    <description>Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Subsequent Therapy for Prostate Cancer</measure>
    <time_frame>Up to 66 months</time_frame>
    <description>Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Pain Progression</measure>
    <time_frame>Up to 66 months</time_frame>
    <description>Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (&gt;=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (&gt;=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing &quot;no pain&quot; and 10 representing&quot; pain as bad as you can imagine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Skeletal-Related Event</measure>
    <time_frame>Up to 66 months</time_frame>
    <description>Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Prostate-Specific Antigen (PSA) Progression</measure>
    <time_frame>Up to 66 months</time_frame>
    <description>Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1209</enrollment>
  <condition>Prostate Neoplasms</condition>
  <arm_group>
    <arm_group_label>Abiraterone acetate + Prednisone + ADT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) will be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Androgen Deprivation Therapy (ADT)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate</intervention_name>
    <description>Abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day until disease progression, withdrawal of consent or unacceptable toxicity.</description>
    <arm_group_label>Abiraterone acetate + Prednisone + ADT</arm_group_label>
    <other_name>Zytiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.</description>
    <arm_group_label>Abiraterone acetate + Prednisone + ADT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Androgen deprivation therapy (ADT)</intervention_name>
    <description>All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.</description>
    <arm_group_label>Abiraterone acetate + Prednisone + ADT</arm_group_label>
    <arm_group_label>Placebo + Androgen Deprivation Therapy (ADT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate Placebo</intervention_name>
    <description>Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.</description>
    <arm_group_label>Placebo + Androgen Deprivation Therapy (ADT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone Placebo</intervention_name>
    <description>Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.</description>
    <arm_group_label>Placebo + Androgen Deprivation Therapy (ADT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with&#xD;
             histologically or cytologically confirmed adenocarcinoma of the prostate without&#xD;
             neuroendocrine differentiation or small cell histology&#xD;
&#xD;
          -  Distant metastatic disease documented by positive bone scan or metastatic lesions on&#xD;
             computed tomography (CT) or magnetic resonance imaging (MRI) scan&#xD;
&#xD;
          -  At least 2 of the following high-risk prognostic factors: Gleason score of greater&#xD;
             than or equal to (&gt;=8); presence of 3 or more lesions on bone scan; presence of&#xD;
             measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response&#xD;
             Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2&#xD;
&#xD;
          -  Adequate hematologic, hepatic, and renal function&#xD;
&#xD;
          -  Agrees to protocol-defined use of effective contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection or other medical condition that would make prednisone use&#xD;
             contraindicated&#xD;
&#xD;
          -  Any chronic medical condition requiring a higher systemic dose of corticosteroid than&#xD;
             5 mg prednisone per day&#xD;
&#xD;
          -  Pathological finding consistent with small cell carcinoma of the prostate&#xD;
&#xD;
          -  Known brain metastasis&#xD;
&#xD;
          -  Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate&#xD;
             cancer (the following exception are permitted): up to 3 months of androgen deprivation&#xD;
             therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or&#xD;
             orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1;&#xD;
             participants may have one course of palliative radiation or surgical therapy to treat&#xD;
             symptoms resulting from metastatic disease if it was administered at least 28 days&#xD;
             prior to Cycle 1 Day 1)&#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>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cordoba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Rioja</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rosario</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Adelaide</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Footscray</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liverpool</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Malvern</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Randwick</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wahroonga</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bonheiden</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brasschaat</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bruxelles</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charleroi</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Namur</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ottignies</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sint-Niklaas</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yvoir</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barretos</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Belo Horizonte</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Caxias Do Sul</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Curitiba</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ijui</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jau</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Natal</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Novo Hamburgo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Porto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ribeirao Preto</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rio de Janeiro</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salvador</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sao Jose Do Rio Preto</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gabrovo</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamilton</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Quebec</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Su Zhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Floridablanca</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Medellin</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hradec Kralove</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Olomouc</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plzen</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Praha 10</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Praha 2</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Praha 4</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aarhus N.</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Holsterbro</city>
        <country>Denmark</country>
      </address>
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  <location>
    <facility>
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        <city>Odense N/a</city>
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      </address>
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  <location>
    <facility>
      <address>
        <city>Roskilde</city>
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    <facility>
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    <facility>
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  <location>
    <facility>
      <address>
        <city>Tampere</city>
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    <facility>
      <address>
        <city>La Chaussee St Victor</city>
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  <location>
    <facility>
      <address>
        <city>Lille</city>
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  <location>
    <facility>
      <address>
        <city>Montpellier</city>
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  <location>
    <facility>
      <address>
        <city>Paris Cedex 14</city>
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  <location>
    <facility>
      <address>
        <city>Suresnes</city>
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  <location>
    <facility>
      <address>
        <city>Toulouse</city>
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  <location>
    <facility>
      <address>
        <city>Villejuif Cedex</city>
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  <location>
    <facility>
      <address>
        <city>Düsseldorf</city>
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  <location>
    <facility>
      <address>
        <city>Hamburg</city>
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    <facility>
      <address>
        <city>Nürtingen</city>
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    <facility>
      <address>
        <city>Budapest N/a</city>
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  <location>
    <facility>
      <address>
        <city>Budapest</city>
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  <location>
    <facility>
      <address>
        <city>Győr</city>
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  <location>
    <facility>
      <address>
        <city>Miskolc</city>
        <country>Hungary</country>
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  <location>
    <facility>
      <address>
        <city>Pecs</city>
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  <location>
    <facility>
      <address>
        <city>Szentes</city>
        <country>Hungary</country>
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  <location>
    <facility>
      <address>
        <city>Beer Yaakov</city>
        <country>Israel</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Beer-Sheva</city>
        <country>Israel</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
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  <location>
    <facility>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
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  <location>
    <facility>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
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  <location>
    <facility>
      <address>
        <city>Petah-Tikva</city>
        <country>Israel</country>
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  <location>
    <facility>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
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  <location>
    <facility>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Gifu</city>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Kashiwa</city>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Matsuyama</city>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Nankoku</city>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Osaka-Sayama</city>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Sakura</city>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Tokushima</city>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Ube</city>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
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  <location>
    <facility>
      <address>
        <city>Yufu</city>
        <country>Japan</country>
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    <facility>
      <address>
        <city>Bucheon-Si</city>
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  <location>
    <facility>
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        <city>Busan</city>
        <country>Korea, Republic of</country>
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    <facility>
      <address>
        <city>Daegu</city>
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        <city>Daejeon</city>
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    <facility>
      <address>
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      <address>
        <city>Kuching</city>
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        <city>Chihuahua</city>
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    <facility>
      <address>
        <city>Cuernavaca</city>
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    <facility>
      <address>
        <city>Durango</city>
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    <facility>
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        <city>Guadalajara</city>
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      <address>
        <city>Pachuca de Soto</city>
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    <facility>
      <address>
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    <facility>
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    <facility>
      <address>
        <city>Yoshkar-Ola</city>
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    <facility>
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        <city>Khakhiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lviv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Makiivka</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Odessa</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Uzhgorod</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zaporizhzhia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>China</country>
    <country>Colombia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Peru</country>
    <country>Singapore</country>
  </removed_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>March 9, 2018</results_first_submitted>
  <results_first_submitted_qc>March 9, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 15, 2018</results_first_posted>
  <disposition_first_submitted>November 20, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>December 20, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 21, 2017</disposition_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate neoplasms</keyword>
  <keyword>Prostate cancer</keyword>
  <keyword>Metastatic prostate cancer</keyword>
  <keyword>Abiraterone acetate</keyword>
  <keyword>ZYTIGA</keyword>
  <keyword>Prednisone</keyword>
  <keyword>Androgen deprivation therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Abiraterone Acetate</mesh_term>
    <mesh_term>Androgens</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>1209 participants were enrolled and 1199 were randomized to treatment groups.10 participants from Russian site were excluded from the analysis due to noncompliance with International Conference on Harmonization Good Clinical Practice guidelines at site. The remaining 1199 randomized participants comprised the intent-to-treat population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Abiraterone Acetate+Prednisone+ADT</title>
          <description>Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.</description>
        </group>
        <group group_id="P2">
          <title>Placebo + ADT</title>
          <description>Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.</description>
        </group>
        <group group_id="P3">
          <title>DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate</title>
          <description>Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate plus Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double Blind Period (Up to 23 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="597"/>
                <participants group_id="P2" count="602"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="597"/>
                <participants group_id="P2" count="602"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="47"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="254"/>
                <participants group_id="P2" count="388"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance With Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Placebo Cross-Over</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="72"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="167"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>OLE Phase (Up to 15.6 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="72">Post unblinding, participants crossed over to OLE Phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="72"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="60"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-Treat (ITT) analysis set included all participants randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. .</population>
      <group_list>
        <group group_id="B1">
          <title>Abiraterone Acetate+Prednisone+ADT</title>
          <description>Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.</description>
        </group>
        <group group_id="B2">
          <title>Placebo + ADT</title>
          <description>Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.</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="597"/>
            <count group_id="B2" value="602"/>
            <count group_id="B3" value="1199"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;=18 years</title>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="221"/>
                    <measurement group_id="B2" value="233"/>
                    <measurement group_id="B3" value="454"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="376"/>
                    <measurement group_id="B2" value="369"/>
                    <measurement group_id="B3" value="745"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.3" spread="8.48"/>
                    <measurement group_id="B2" value="66.8" spread="8.72"/>
                    <measurement group_id="B3" value="67.1" spread="8.6"/>
                  </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="597"/>
                    <measurement group_id="B2" value="602"/>
                    <measurement group_id="B3" value="1199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <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>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colombia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czech Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaysia</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>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Zeland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russian Federation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Turkey</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Radiographic Progression-Free Survival (PFS)</title>
        <description>Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 [PCWG2] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.</description>
        <time_frame>Up to 44 months</time_frame>
        <population>Intention to treat (ITT) analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate+Prednisone+ADT</title>
            <description>Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + ADT</title>
            <description>Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic Progression-Free Survival (PFS)</title>
          <description>Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 [PCWG2] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.</description>
          <population>Intention to treat (ITT) analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="597"/>
                <count group_id="O2" value="602"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.02" lower_limit="29.57" upper_limit="NA">Here 'NA' represents that upper limit of 95% CI was not estimable due to lesser number of events.</measurement>
                    <measurement group_id="O2" value="14.78" lower_limit="14.69" upper_limit="18.27"/>
                  </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>&lt;0.0001</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.466</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.394</ci_lower_limit>
            <ci_upper_limit>0.550</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival was defined as the time from randomization to date of death from any cause.</description>
        <time_frame>Up to 66 months</time_frame>
        <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate+Prednisone+ADT</title>
            <description>Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + ADT</title>
            <description>Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall survival was defined as the time from randomization to date of death from any cause.</description>
          <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="597"/>
                <count group_id="O2" value="602"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.32" lower_limit="48.23" upper_limit="NA">Here 'NA' represents that upper limit of 95% CI was not estimable due to lesser number of events.</measurement>
                    <measurement group_id="O2" value="36.53" lower_limit="33.54" upper_limit="39.95"/>
                  </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>&lt; 0.0001</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.661</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.564</ci_lower_limit>
            <ci_upper_limit>0.775</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Initiation of Chemotherapy</title>
        <description>Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.</description>
        <time_frame>Up to 66 months</time_frame>
        <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate+Prednisone+ADT</title>
            <description>Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + ADT</title>
            <description>Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Initiation of Chemotherapy</title>
          <description>Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.</description>
          <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="597"/>
                <count group_id="O2" value="602"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="62.62" upper_limit="NA">Here, 'NA' indicates that the median and upper limit of 95% CI was not estimated due to lesser number of events.</measurement>
                    <measurement group_id="O2" value="57.59" lower_limit="38.18" upper_limit="NA">Here, 'NA' indicates that the upper limit of 95% CI was not estimated due to lesser number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Subsequent Therapy for Prostate Cancer</title>
        <description>Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.</description>
        <time_frame>Up to 66 months</time_frame>
        <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate+Prednisone+ADT</title>
            <description>Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + ADT</title>
            <description>Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Subsequent Therapy for Prostate Cancer</title>
          <description>Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.</description>
          <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="597"/>
                <count group_id="O2" value="602"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.87" lower_limit="46.42" upper_limit="NA">Here 'NA' indicates that the upper limit of 95% CI was not estimated due to lesser number of events.</measurement>
                    <measurement group_id="O2" value="21.22" lower_limit="18.56" upper_limit="23.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Pain Progression</title>
        <description>Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (&gt;=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (&gt;=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing &quot;no pain&quot; and 10 representing&quot; pain as bad as you can imagine.</description>
        <time_frame>Up to 66 months</time_frame>
        <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate+Prednisone+ADT</title>
            <description>Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + ADT</title>
            <description>Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Pain Progression</title>
          <description>Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (&gt;=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (&gt;=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing &quot;no pain&quot; and 10 representing&quot; pain as bad as you can imagine.</description>
          <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="597"/>
                <count group_id="O2" value="602"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.41" lower_limit="33.15" upper_limit="NA">Here 'NA' represents that upper limit of 95% CI was not estimable due to lesser number of events.</measurement>
                    <measurement group_id="O2" value="16.62" lower_limit="11.07" upper_limit="23.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Skeletal-Related Event</title>
        <description>Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.</description>
        <time_frame>Up to 66 months</time_frame>
        <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate+Prednisone+ADT</title>
            <description>Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + ADT</title>
            <description>Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Skeletal-Related Event</title>
          <description>Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.</description>
          <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="597"/>
                <count group_id="O2" value="602"/>
              </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">Here 'NA' represents that median, upper limit and lower limit of 95% CI was not estimable due to lesser number of events.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Here 'NA' represents that median, upper limit and lower limit of 95% CI was not estimable due to lesser number of events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Prostate-Specific Antigen (PSA) Progression</title>
        <description>Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.</description>
        <time_frame>Up to 66 months</time_frame>
        <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Abiraterone Acetate+Prednisone+ADT</title>
            <description>Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + ADT</title>
            <description>Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Prostate-Specific Antigen (PSA) Progression</title>
          <description>Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.</description>
          <population>ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="597"/>
                <count group_id="O2" value="602"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.31" lower_limit="29.44" upper_limit="46.09"/>
                    <measurement group_id="O2" value="7.43" lower_limit="7.20" upper_limit="9.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Day 1 up to 30 days post last dose (that is, for DB period: up to 23 months and OLE period: up to 15.6 months), deaths were collected from baseline up to end of study (up to 66 months).</time_frame>
      <desc>Safety analysis set included all participants randomized into the study and who received any part of study drug. Only 72 deaths out of all cause mortalities contributed to discontinuation.</desc>
      <group_list>
        <group group_id="E1">
          <title>Abiraterone Acetate+Prednisone+ADT</title>
          <description>Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.</description>
        </group>
        <group group_id="E2">
          <title>Placebo + ADT</title>
          <description>Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.</description>
        </group>
        <group group_id="E3">
          <title>DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate</title>
          <description>Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate plus Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 18.0</default_vocab>
        <default_assessment>Non-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="597"/>
                <counts group_id="E2" subjects_affected="339" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="192" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="151" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Coronary Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Mitral Valve Incompetence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Myocardial Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Sinus Node Dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Phimosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dental Caries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Duodenal Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastric Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastric Ulcer Perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Intestinal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Intestinal Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Mouth Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Peptic Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Rectal Polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Device Dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hernia Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Multi-Organ Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Peripheral Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile Duct Stone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hepatitis Toxic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hepatobiliary Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hepatocellular Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bursitis Infective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cellulitis Orbital</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Device Related Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Eye Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Fungaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Localised Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Orchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Osteomyelitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Otitis Media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pyelonephritis Acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pyelonephritis Chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Spinal Cord Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Staphylococcal Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femoral Neck Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Head Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Kidney Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Ligament Sprain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lower Limb Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lumbar Vertebral Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Patella Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pneumothorax Traumatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Post Procedural Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Procedural Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pubis Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Spinal Compression Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Thermal Burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Traumatic Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Traumatic Intracranial Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Upper Limb Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Biopsy Liver</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Blood Glucose Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Blood Testosterone Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Diabetes Mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Metabolic Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gouty Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of Jaw</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pain in Jaw</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pathological Fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Spinal Column Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Spondylitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Trismus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of Colon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>B-Cell Lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bladder Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bladder Transitional Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cancer Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chronic Lymphocytic Leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chronic Lymphocytic Leukaemia Stage 3</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chronic Myeloid Leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Colon Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Colon Neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lentigo Maligna</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lung Adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Malignant Melanoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Malignant Neoplasm of Renal Pelvis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Metastases to Meninges</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Neoplasm Malignant</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Neoplasm of Thymus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Neuroendocrine Tumour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Oesophageal Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Plasma Cell Myeloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Rectal Cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Transitional Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Brain Compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Carotid Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cerebral Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cerebral Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cognitive Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Guillain-Barre Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Haemorrhagic Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lacunar Infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Loss of Consciousness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Myasthenia Gravis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Nerve Compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Optic Nerve Compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Paraplegia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Radiculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Speech Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Spinal Cord Compression</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Vascular Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Mental Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bladder Outlet Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Calculus Bladder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Calculus Ureteric</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chronic Kidney Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lower Urinary Tract Symptoms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Micturition Urgency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Renal Injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Ureteric Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Urethral Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Urethral Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Urinary Tract Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </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" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pelvic Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Prostatic Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bronchitis Chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pneumonia Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pulmonary Mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pulmonary Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin Lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Lipoma Excision</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Angiopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Aortic Aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Aortic Dissection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Blood Pressure Fluctuation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Intermittent Claudication</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Peripheral Vascular Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 18.0</default_vocab>
        <default_assessment>Non-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="533" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="515" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="35" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="89" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="68" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="67" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="84" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="90" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="100" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="77" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Blood Lactate Dehydrogenase Increased</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="72" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="143" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="96" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="86" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="120" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="122" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" subjects_affected="81" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="90" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="72" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="69" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot Flush</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="229" subjects_at_risk="597"/>
                <counts group_id="E2" subjects_affected="133" subjects_at_risk="602"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="72"/>
              </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 an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>As per protocol the long-term extension (LTE) phase was planned but LTE phase is not included as part of this study hence no data was reported for LTE phase.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Senior Director Clinical Development</name_or_title>
      <organization>Janssen Research &amp; Development, LLC</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@its.jnj.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/NCT01715285
org study id: CR100900
secondary id: 212082PCR3011
secondary id: 2012-002940-26
secondary id: U1111-1135-7146
nct id: NCT01715285
lead sponsor: 
has dmc: Yes
is fda regulated device: No
The purpose of this study is to determine if newly diagnosed (within previous 3 months)
      participants with metastatic (spread of cancer cells from one part of the body to another )
      hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from
      the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy
      (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).
This is a randomized (the treatment group is assigned by chance), double-blind (neither
      physician nor participant knows the treatment that the participant receives), placebo (an
      inactive substance that is compared with a drug to test whether the drug has a real effect in
      a clinical trial)-controlled study designed to determine the efficacy of abiraterone acetate
      plus low-dose prednisone in participants with mHNPC. The study consists of 4 parts: Screening
      Phase (that is, 28 days before study commences on Day 1); Double-blind treatment Phase
      (consists of 4-week dosing cycles wherein abiraterone acetate will be administered as 1,000
      milligram [mg] plus 5 mg prednisone or only placebo orally); Follow-up Phase (every 4 months
      up to 60 months or until death, lost to follow up, withdrawal of consent or study
      termination) Open-label Extension (OLE) Phase. Participants in the Double-blind Treatment
      Phase will have the opportunity to enroll into the OLE Phase. The OLE Phase will allow
      participants to receive active drug (abiraterone acetate plus prednisone) until Long-term
      Extension (LTE) Phase for an additional period of up to 3 years. Participants will
      discontinue study treatment at disease progression or unacceptable toxicity unless, in the
      Investigator's opinion, it is deemed that the participants will continue to derive benefit
      from study treatment. Participants will be randomized in a 1:1 ratio to the active treatment
      group (abiraterone acetate 1000 mg daily plus prednisone 5 mg daily plus ADT) or the control
      group (ADT plus placebos).Efficacy will be evaluated primarily by overall survival and
      radiographic progression-free survival. Participants' safety will be monitored throughout the
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Radiographic Progression-Free Survival (PFS)
time frame: Up to 44 months
description: Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 [PCWG2] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.
measure: Overall Survival (OS)
time frame: Up to 66 months
description: Overall survival was defined as the time from randomization to date of death from any cause.
measure: Time to Initiation of Chemotherapy
time frame: Up to 66 months
description: Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
measure: Time to Subsequent Therapy for Prostate Cancer
time frame: Up to 66 months
description: Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.
measure: Time to Pain Progression
time frame: Up to 66 months
description: Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.
measure: Time to Skeletal-Related Event
time frame: Up to 66 months
description: Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.
measure: Time to Prostate-Specific Antigen (PSA) Progression
time frame: Up to 66 months
description: Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.
arm group label: Abiraterone acetate + Prednisone + ADT
arm group type: Experimental
description: Participants will receive abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) will be administered.
arm group label: Placebo + Androgen Deprivation Therapy (ADT)
arm group type: Placebo Comparator
description: Participants will receive placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT will be administered.
intervention type: Drug
intervention name: Abiraterone acetate
description: Abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day until disease progression, withdrawal of consent or unacceptable toxicity.
arm group label: Abiraterone acetate + Prednisone + ADT
other name: Zytiga
intervention type: Drug
intervention name: Prednisone
description: Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
arm group label: Abiraterone acetate + Prednisone + ADT
intervention type: Other
intervention name: Androgen deprivation therapy (ADT)
description: All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.
arm group label: Abiraterone acetate + Prednisone + ADT
arm group label: Placebo + Androgen Deprivation Therapy (ADT)
intervention type: Drug
intervention name: Abiraterone acetate Placebo
description: Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
arm group label: Placebo + Androgen Deprivation Therapy (ADT)
intervention type: Drug
intervention name: Prednisone Placebo
description: Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
arm group label: Placebo + Androgen Deprivation Therapy (ADT)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Argentina
country: Australia
country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: Chile
country: China
country: Colombia
country: Czechia
country: Denmark
country: Finland
country: France
country: Germany
country: Hungary
country: Israel
country: Japan
country: Korea, Republic of
country: Malaysia
country: Mexico
country: Netherlands
country: New Zealand
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Slovakia
country: South Africa
country: Spain
country: Sweden
country: Turkey
country: Ukraine
country: United Kingdom
country: Czech Republic
country: Peru
country: Singapore
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prednisone
mesh term: Abiraterone Acetate
mesh term: Androgens
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: As per protocol the long-term extension (LTE) phase was planned but LTE phase is not included as part of this study hence no data was reported for LTE phase.
point of contact: 