<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/NCT01695135</url>
  </required_header>
  <id_info>
    <org_study_id>CR100010</org_study_id>
    <secondary_id>ABI-PRO-3001</secondary_id>
    <nct_id>NCT01695135</nct_id>
  </id_info>
  <brief_title>A Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy</brief_title>
  <official_title>A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when&#xD;
      co-administered with prednisone in Asian patients with metastatic castration-resistant&#xD;
      prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (the treatment group is assigned by chance), double-blind (neither&#xD;
      physician nor patient knows the treatment that the patient receives) placebo (an inactive&#xD;
      substance that is compared with a drug to test whether the drug has a real effect in a&#xD;
      clinical trial)-controlled study with a randomization allocation ratio of 2:1 between the&#xD;
      abiraterone acetate group (abiraterone acetate plus prednisone) and the placebo group&#xD;
      (placebo plus prednisone). Approximately 200 (133 in the abiraterone acetate group and 67 in&#xD;
      the placebo group) medically or surgically castrated male patients with mCRPC who have failed&#xD;
      docetaxel-based chemotherapy will be enrolled in this study for up to 27 months. The study&#xD;
      protocol includes the following phases: screening (within 28 days prior to randomization on&#xD;
      Cycle 1 Day 1), double-blind treatment (28-day cycles until protocol-defined disease&#xD;
      progression or unacceptable toxicity), and survival follow-up (up to Month 60). During the&#xD;
      follow-up phase, patients with disease progression will be provided open-label (identity of&#xD;
      assigned study drug will be known) extension treatment with abiraterone acetate. In the event&#xD;
      of a positive study result at the time of the final analysis, participants in the placebo&#xD;
      group who have not shown progressive disease in the double-blind treatment Phase of the study&#xD;
      will be enrolled in an open-label extension treatment with abiraterone acetate treatment&#xD;
      based on the participant's choice and treating physician's endorsement if they meet the&#xD;
      criteria for subsequent abiraterone acetate. Abiraterone acetate 1000 mg tablets or placebo&#xD;
      will be taken orally (by mouth) once daily plus prednisone 5 mg tablet orally twice daily.&#xD;
      Efficacy and safety will be monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2012</start_date>
  <completion_date type="Actual">May 8, 2018</completion_date>
  <primary_completion_date type="Actual">June 20, 2014</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>DB Phase: Time to Prostate-Specific Antigen Progression (PSA)</measure>
    <time_frame>Up to 1.8 years</time_frame>
    <description>Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (&gt;=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: &gt;=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: &gt;=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DB Phase: Overall Survival</measure>
    <time_frame>From randomization to the date of death due to any cause (up to approximately 3.8 years)</time_frame>
    <description>Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DB Phase: Percentage of Participants Who Achieved PSA Response</measure>
    <time_frame>Approximately up to 3.8 years</time_frame>
    <description>Percentage of participants who achieved PSA response (defined as &gt;= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: &gt;= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: &gt;=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: &gt;=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DB Phase: Objective Response Rate (ORR)</measure>
    <time_frame>Approximately up to 3.8 years</time_frame>
    <description>ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment</measure>
    <time_frame>Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])</time_frame>
    <description>FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DB Phase: Time to Pain Progression</measure>
    <time_frame>Approximately up to 3.8 years</time_frame>
    <description>Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of &gt;=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score &gt;=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DB Phase: Percentage of Participants Experiencing Pain Palliation</measure>
    <time_frame>Approximately up to 3.8 years</time_frame>
    <description>Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced &gt;=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment</measure>
    <time_frame>Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])</time_frame>
    <description>The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its &quot;worst,&quot; &quot;usual,&quot; and &quot;now&quot; during normal waking hours, with 0 being &quot;no fatigue&quot; and 10 being &quot;fatigue as bad as you can imagine.&quot; Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being &quot;does not interfere&quot; and 10 being &quot;completely interferes.&quot; BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">214</enrollment>
  <condition>Prostate Neoplasms</condition>
  <arm_group>
    <arm_group_label>Abiraterone acetate plus prednisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo plus prednisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone acetate</intervention_name>
    <description>Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily</description>
    <arm_group_label>Abiraterone acetate plus prednisone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (4 tablets) taken orally once daily</description>
    <arm_group_label>Placebo plus prednisone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Prednisone 5 mg tablet taken orally twice daily</description>
    <arm_group_label>Abiraterone acetate plus prednisone</arm_group_label>
    <arm_group_label>Placebo plus prednisone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed adenocarcinoma of the prostate except&#xD;
             neuroendocrine carcinoma including small cell carcinoma&#xD;
&#xD;
          -  Disease progressed on or after prior docetaxel-containing chemotherapy&#xD;
&#xD;
          -  Prior 1 or 2 cytotoxic chemotherapy regimens for metastatic castration-resistant&#xD;
             prostate cancer, at least 1 of which contains docetaxel&#xD;
&#xD;
          -  Documented prostate cancer progression as documented by prostate specific antigen&#xD;
             progression according to Prostate Specific Antigen Working Group criteria or&#xD;
             radiographic progression in soft tissue or bone&#xD;
&#xD;
          -  Surgically or medically castrated, with serum testosterone level &lt;50 ng/dL (1.7&#xD;
             nmol/L)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status score of &lt;=2&#xD;
&#xD;
          -  Protocol-defined laboratory values&#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&#xD;
             (corticosteroid) use contraindicated&#xD;
&#xD;
          -  Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg&#xD;
             prednisone twice daily&#xD;
&#xD;
          -  Pathological finding consistent with neuroendocrine carcinoma of prostate including&#xD;
             small cell carcinoma&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic BP &gt;=160 mmHg or diastolic BP &gt;=95 mmHg; patients&#xD;
             with a history of hypertension are allowed provided blood pressure is controlled by&#xD;
             anti-hypertensive therapy)&#xD;
&#xD;
          -  Active or symptomatic viral hepatitis or chronic liver disease, have a known infection&#xD;
             with human immunodeficiency virus and/or hepatitis B virus or hepatitis C virus&#xD;
&#xD;
          -  History of pituitary or adrenal dysfunction.&#xD;
&#xD;
          -  Clinically significant heart disease as evidenced by myocardial infarction, or&#xD;
             arterial thrombotic events in the past 6 months, severe or unstable angina, or New&#xD;
             York Heart Association Class III or IV heart disease or cardiac ejection fraction&#xD;
             measurement of &lt;50% at baseline&#xD;
&#xD;
          -  Atrial fibrillation, or other cardiac arrhythmia requiring therapy&#xD;
&#xD;
          -  Other malignancy within past 3 years (except basal or nonmetastatic squamous cell&#xD;
             carcinoma of the skin)&#xD;
&#xD;
          -  Known brain metastasis&#xD;
&#xD;
          -  Prior therapy with abiraterone acetate or other CYP17 inhibitor(s), or investigational&#xD;
             agent(s) targeting the androgen receptor for metastatic prostate cancer&#xD;
&#xD;
          -  Prior therapy with ketoconazole for prostate cancer&#xD;
&#xD;
          -  Surgery or local prostatic intervention within 30 days of the first dose&#xD;
&#xD;
          -  Radiotherapy, chemotherapy, or immunotherapy within 30 days, or single fraction of&#xD;
             palliative radiotherapy within 14 days of administration of Cycle 1 Day 1&#xD;
&#xD;
          -  Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not&#xD;
             resolved to a National Cancer Institute-Common Terminology Criteria for Adverse Events&#xD;
             grade of &lt;=1 (chemotherapy induced alopecia and grade 2 peripheral neuropathy is&#xD;
             allowed)&#xD;
&#xD;
          -  Current enrollment in an investigational drug or device study or participation in such&#xD;
             a study within 30 days of Cycle 1 Day 1&#xD;
&#xD;
          -  Anti-androgen treatment must not be given within 4 weeks (flutamide) or 6 weeks&#xD;
             (bicalutamide or nilutamide) prior to Cycle 1 Day 1&#xD;
&#xD;
          -  Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole) within 4&#xD;
             weeks prior to Cycle 1 Day 1&#xD;
&#xD;
          -  Has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its&#xD;
             excipients&#xD;
&#xD;
          -  Has contraindications to the use of prednisone per local prescribing information&#xD;
&#xD;
          -  Has any condition that, in the opinion of the investigator, would make participation&#xD;
             not be in the best interest (eg, compromise the well-being) of the patient or that&#xD;
             could prevent, limit, or confound the protocol-specified assessments&#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>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Changsha</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>Wenzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <removed_countries>
    <country>Vietnam</country>
  </removed_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <results_first_submitted>May 7, 2019</results_first_submitted>
  <results_first_submitted_qc>May 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 18, 2019</results_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate neoplasms</keyword>
  <keyword>Prostate cancer</keyword>
  <keyword>Metastatic castration resistant prostate cancer</keyword>
  <keyword>Abiraterone acetate</keyword>
  <keyword>JNJ-212082</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>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 214 participants were enrolled in the study (143 participants in abiraterone acetate group and 71 participants in placebo group).</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo + Prednisone (Double-blind [DB])</title>
          <description>Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
        </group>
        <group group_id="P2">
          <title>Abiraterone Acetate + Prednisone (Double-blind)</title>
          <description>Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
        </group>
        <group group_id="P3">
          <title>Placebo + Prednisone (DB) to AA + Prednisone (Open-label)</title>
          <description>Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.</description>
        </group>
        <group group_id="P4">
          <title>AA + Prednisone to AA + Prednisone (Open-label)</title>
          <description>Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-blind Treatment Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="143"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="139"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Progressive disease</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="110"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance with study drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open Label Extension Treatment Phase</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="49"/>
                <participants group_id="P4" count="80"/>
              </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="9"/>
                <participants group_id="P4" count="10"/>
              </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="40"/>
                <participants group_id="P4" count="70"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <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="13"/>
                <participants group_id="P4" count="22"/>
              </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 group_id="P4" count="16"/>
              </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="11"/>
                <participants group_id="P4" count="16"/>
              </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="4"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <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="2"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance with study drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo + Prednisone (Double-blind)</title>
          <description>Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
        </group>
        <group group_id="B2">
          <title>Abiraterone Acetate + Prednisone (Double-blind)</title>
          <description>Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</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="71"/>
            <count group_id="B2" value="143"/>
            <count group_id="B3" value="214"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.7" spread="7.75"/>
                    <measurement group_id="B2" value="68.2" spread="8.3"/>
                    <measurement group_id="B3" value="68" spread="8.11"/>
                  </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="71"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="214"/>
                  </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>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>DB Phase: Time to Prostate-Specific Antigen Progression (PSA)</title>
        <description>Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (&gt;=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: &gt;=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: &gt;=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.</description>
        <time_frame>Up to 1.8 years</time_frame>
        <population>Intent-to-Treat (ITT) analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Prednisone (Double-blind)</title>
            <description>Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Abiraterone Acetate + Prednisone (Double-blind)</title>
            <description>Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>DB Phase: Time to Prostate-Specific Antigen Progression (PSA)</title>
          <description>Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (&gt;=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: &gt;=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: &gt;=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.</description>
          <population>Intent-to-Treat (ITT) analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.</population>
          <units>Days</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="71"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.00" lower_limit="31.00" upper_limit="113.00"/>
                    <measurement group_id="O2" value="169.00" lower_limit="141.00" upper_limit="197.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.528</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.376</ci_lower_limit>
            <ci_upper_limit>0.740</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DB Phase: Overall Survival</title>
        <description>Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.</description>
        <time_frame>From randomization to the date of death due to any cause (up to approximately 3.8 years)</time_frame>
        <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Prednisone (Double-blind)</title>
            <description>Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Abiraterone Acetate + Prednisone (Double-blind)</title>
            <description>Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>DB Phase: Overall Survival</title>
          <description>Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.</description>
          <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.</population>
          <units>Days</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="71"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="561.00" lower_limit="352.00" upper_limit="787.00"/>
                    <measurement group_id="O2" value="579.00" lower_limit="504.00" upper_limit="731.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DB Phase: Percentage of Participants Who Achieved PSA Response</title>
        <description>Percentage of participants who achieved PSA response (defined as &gt;= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: &gt;= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: &gt;=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: &gt;=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.</description>
        <time_frame>Approximately up to 3.8 years</time_frame>
        <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Prednisone (Double-blind)</title>
            <description>Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Abiraterone Acetate + Prednisone (Double-blind)</title>
            <description>Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>DB Phase: Percentage of Participants Who Achieved PSA Response</title>
          <description>Percentage of participants who achieved PSA response (defined as &gt;= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: &gt;= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: &gt;=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: &gt;=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.</description>
          <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3"/>
                    <measurement group_id="O2" value="54.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DB Phase: Objective Response Rate (ORR)</title>
        <description>ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.</description>
        <time_frame>Approximately up to 3.8 years</time_frame>
        <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants with measurable disease at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Prednisone (Double-blind)</title>
            <description>Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Abiraterone Acetate + Prednisone (Double-blind)</title>
            <description>Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>DB Phase: Objective Response Rate (ORR)</title>
          <description>ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.</description>
          <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants with measurable disease at baseline.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2"/>
                    <measurement group_id="O2" value="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment</title>
        <description>FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better).</description>
        <time_frame>Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])</time_frame>
        <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Prednisone (Double-blind)</title>
            <description>Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Abiraterone Acetate + Prednisone (Double-blind)</title>
            <description>Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment</title>
          <description>FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better).</description>
          <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.9" spread="22.07"/>
                    <measurement group_id="O2" value="-16.1" spread="22.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Well-being</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.7" spread="6.52"/>
                    <measurement group_id="O2" value="-4.9" spread="6.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Functional Well-being</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="6.60"/>
                    <measurement group_id="O2" value="-2.7" spread="7.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Well-being</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="4.48"/>
                    <measurement group_id="O2" value="-2.4" spread="4.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Well-being</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="3.82"/>
                    <measurement group_id="O2" value="-1.2" spread="6.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FACT-G Total Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.6" spread="16.25"/>
                    <measurement group_id="O2" value="-11.2" spread="17.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prostate Cancer Subscale (PCS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="7.99"/>
                    <measurement group_id="O2" value="-4.9" spread="7.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Outcome Index (FACT-TOI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.1" spread="17.76"/>
                    <measurement group_id="O2" value="-12.5" spread="17.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DB Phase: Time to Pain Progression</title>
        <description>Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of &gt;=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score &gt;=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain.</description>
        <time_frame>Approximately up to 3.8 years</time_frame>
        <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Prednisone (Double-blind)</title>
            <description>Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Abiraterone Acetate + Prednisone (Double-blind)</title>
            <description>Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>DB Phase: Time to Pain Progression</title>
          <description>Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of &gt;=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score &gt;=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain.</description>
          <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.</population>
          <units>Days</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="71"/>
                <count group_id="O2" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169.00" lower_limit="85.00" upper_limit="253.00"/>
                    <measurement group_id="O2" value="505.00" lower_limit="365.00" upper_limit="NA">Here 'NA' represents that upper limit of Confidence Interval (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>DB Phase: Percentage of Participants Experiencing Pain Palliation</title>
        <description>Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced &gt;=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.</description>
        <time_frame>Approximately up to 3.8 years</time_frame>
        <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants whose pain score was &gt;= 4 at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Prednisone (Double-blind)</title>
            <description>Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Abiraterone Acetate + Prednisone (Double-blind)</title>
            <description>Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>DB Phase: Percentage of Participants Experiencing Pain Palliation</title>
          <description>Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced &gt;=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.</description>
          <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants whose pain score was &gt;= 4 at baseline.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8"/>
                    <measurement group_id="O2" value="54.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment</title>
        <description>The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its &quot;worst,&quot; &quot;usual,&quot; and &quot;now&quot; during normal waking hours, with 0 being &quot;no fatigue&quot; and 10 being &quot;fatigue as bad as you can imagine.&quot; Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being &quot;does not interfere&quot; and 10 being &quot;completely interferes.&quot; BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).</description>
        <time_frame>Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])</time_frame>
        <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo + Prednisone (Double-blind)</title>
            <description>Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
          <group group_id="O2">
            <title>Abiraterone Acetate + Prednisone (Double-blind)</title>
            <description>Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment</title>
          <description>The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its &quot;worst,&quot; &quot;usual,&quot; and &quot;now&quot; during normal waking hours, with 0 being &quot;no fatigue&quot; and 10 being &quot;fatigue as bad as you can imagine.&quot; Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being &quot;does not interfere&quot; and 10 being &quot;completely interferes.&quot; BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).</description>
          <population>ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fatigue Now</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="3.59"/>
                    <measurement group_id="O2" value="1.7" spread="3.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="3.53"/>
                    <measurement group_id="O2" value="1.5" spread="3.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worst Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="3.73"/>
                    <measurement group_id="O2" value="1.6" spread="3.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="3.65"/>
                    <measurement group_id="O2" value="1.7" spread="3.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mood</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="3.39"/>
                    <measurement group_id="O2" value="1.8" spread="3.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walking Ability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="3.28"/>
                    <measurement group_id="O2" value="1.8" spread="3.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal Work</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="3.84"/>
                    <measurement group_id="O2" value="2.0" spread="3.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relations with Other People</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="3.08"/>
                    <measurement group_id="O2" value="1.6" spread="3.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enjoyment of Life</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="3.33"/>
                    <measurement group_id="O2" value="1.9" spread="3.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately up to 3.8 years</time_frame>
      <desc>Safety analysis set included all randomized participants who received at least one dose of study drug and classified to the treatment group according to their actual treatment received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo + Prednisone (Double-blind)</title>
          <description>Participants received placebo (4 tablets) once daily + prednisone 5 milligram (mg) twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
        </group>
        <group group_id="E2">
          <title>Abiraterone Acetate + Prednisone (Double-blind)</title>
          <description>Participants received abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily + prednisone 5 mg twice daily on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Each cycle of 28 days.</description>
        </group>
        <group group_id="E3">
          <title>Placebo + Prednisone (DB) to AA + Prednisone (Open-label)</title>
          <description>Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.</description>
        </group>
        <group group_id="E4">
          <title>AA + Prednisone to AA + Prednisone (Open-label)</title>
          <description>Participants with disease progression during the double-blind treatment phase received abiraterone acetate 1000 mg once daily + prednisone 5 mg twice daily in open-label extension treatment phase based on the participant's choice and treating physician's decision if they met the criteria for subsequent abiraterone acetate treatment until they no longer derive clinical benefit, unacceptable toxicity, initiation of a subsequent anticancer therapy, or serious protocol violation.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="41" subjects_at_risk="80"/>
              </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="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blindness unilateral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrointestinal motility disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Enterovesical fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Multi-organ failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Biliary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pulpitis dental</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="80"/>
              </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="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Musculoskeletal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Spinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Metastases to lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Viith nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ureteric obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urethral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary bladder haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatic haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peripheral embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemorrhagic infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 16.0</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="62" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="134" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="35" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="54" subjects_at_risk="80"/>
              </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="16" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="29" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood phosphorus decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>White blood cells urine positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </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="2" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="143"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="80"/>
              </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>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 in writing, such publication will be withheld for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Director</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/NCT01695135
org study id: CR100010
secondary id: ABI-PRO-3001
nct id: NCT01695135
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when
      co-administered with prednisone in Asian patients with metastatic castration-resistant
      prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy.
This is a randomized (the treatment group is assigned by chance), double-blind (neither
      physician nor patient knows the treatment that the patient 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 with a randomization allocation ratio of 2:1 between the
      abiraterone acetate group (abiraterone acetate plus prednisone) and the placebo group
      (placebo plus prednisone). Approximately 200 (133 in the abiraterone acetate group and 67 in
      the placebo group) medically or surgically castrated male patients with mCRPC who have failed
      docetaxel-based chemotherapy will be enrolled in this study for up to 27 months. The study
      protocol includes the following phases: screening (within 28 days prior to randomization on
      Cycle 1 Day 1), double-blind treatment (28-day cycles until protocol-defined disease
      progression or unacceptable toxicity), and survival follow-up (up to Month 60). During the
      follow-up phase, patients with disease progression will be provided open-label (identity of
      assigned study drug will be known) extension treatment with abiraterone acetate. In the event
      of a positive study result at the time of the final analysis, participants in the placebo
      group who have not shown progressive disease in the double-blind treatment Phase of the study
      will be enrolled in an open-label extension treatment with abiraterone acetate treatment
      based on the participant's choice and treating physician's endorsement if they meet the
      criteria for subsequent abiraterone acetate. Abiraterone acetate 1000 mg tablets or placebo
      will be taken orally (by mouth) once daily plus prednisone 5 mg tablet orally twice daily.
      Efficacy and safety will be monitored throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: DB Phase: Time to Prostate-Specific Antigen Progression (PSA)
time frame: Up to 1.8 years
description: Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (>=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.
measure: DB Phase: Overall Survival
time frame: From randomization to the date of death due to any cause (up to approximately 3.8 years)
description: Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.
measure: DB Phase: Percentage of Participants Who Achieved PSA Response
time frame: Approximately up to 3.8 years
description: Percentage of participants who achieved PSA response (defined as >= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: >= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.
measure: DB Phase: Objective Response Rate (ORR)
time frame: Approximately up to 3.8 years
description: ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
measure: DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
time frame: Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])
description: FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better).
measure: DB Phase: Time to Pain Progression
time frame: Approximately up to 3.8 years
description: Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of >=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score >=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain.
measure: DB Phase: Percentage of Participants Experiencing Pain Palliation
time frame: Approximately up to 3.8 years
description: Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced >=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.
measure: DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
time frame: Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])
description: The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being "does not interfere" and 10 being "completely interferes." BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).
arm group label: Abiraterone acetate plus prednisone
arm group type: Experimental
arm group label: Placebo plus prednisone
arm group type: Experimental
intervention type: Drug
intervention name: Abiraterone acetate
description: Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily
arm group label: Abiraterone acetate plus prednisone
intervention type: Drug
intervention name: Placebo
description: Placebo (4 tablets) taken orally once daily
arm group label: Placebo plus prednisone
intervention type: Drug
intervention name: Prednisone
description: Prednisone 5 mg tablet taken orally twice daily
arm group label: Abiraterone acetate plus prednisone
arm group label: Placebo plus prednisone
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: China
country: Vietnam
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prednisone
mesh term: Abiraterone Acetate
participant flow: 
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certain agreements: 
point of contact: 