<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/NCT01666314</url>
  </required_header>
  <id_info>
    <org_study_id>C21013</org_study_id>
    <secondary_id>2012-001539-30</secondary_id>
    <secondary_id>U1111-1179-5750</secondary_id>
    <nct_id>NCT01666314</nct_id>
  </id_info>
  <brief_title>Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer</brief_title>
  <official_title>A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Patients With Castration-Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Millennium Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the&#xD;
      pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly&#xD;
      with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called orteronel. Orteronel is being tested to treat&#xD;
      adult males who have adenocarcinoma of the prostate. This study will look at the&#xD;
      pharmacokinetics (how the drug moves through the body) and pharmacodynamics (how the drug&#xD;
      effects the body) in people who take orteronel in addition to prednisone.&#xD;
&#xD;
      The study will enroll approximately 144 patients. Participants will be randomly assigned (by&#xD;
      chance, like flipping a coin) to one of the eight treatment groups (4 in Japan, 4 in&#xD;
      Ex-Japan) which will remain undisclosed to the participant and study doctor during the study&#xD;
      (unless there is an urgent medical need).&#xD;
&#xD;
      In Japan:&#xD;
&#xD;
      Participants were randomized in a ratio of 2:1:2:1&#xD;
&#xD;
        -  200 mg orteronel or Placebo-matching orteronel [(dummy inactive pill) - this is a tablet&#xD;
           that looks like the study drug but has no active ingredient] twice daily (BID) +&#xD;
           prednisone&#xD;
&#xD;
        -  300 mg orteronel, or Placebo-matching orteronel, BID + prednisone Ex-Japan Participants&#xD;
           were randomized in a ratio of 2:1:2:1&#xD;
&#xD;
        -  200 mg orteronel or Placebo-matching orteronel, BID in Cycle 1 + prednisone&#xD;
&#xD;
        -  400 mg orteronel, or Placebo-matching orteronel ,BID in Cycle 1 + Prednisone&#xD;
&#xD;
      Participants initially randomized to placebo received 4 weeks of placebo and then 12 weeks of&#xD;
      active treatment with orteronel then entered a follow-up period treatment period.&#xD;
      Participants initially randomized to orteronel received 16 weeks of treatment then entered a&#xD;
      follow-up treatment period.&#xD;
&#xD;
      This multi-centre trial will be conducted worldwide. The overall time to participate in this&#xD;
      study is approximately 3.2 years. Participants will make multiple visits to the clinic and a&#xD;
      final visit 30 to 40 days after receiving their last dose of study drug for a follow-up&#xD;
      assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2012</start_date>
  <completion_date type="Actual">September 1, 2016</completion_date>
  <primary_completion_date type="Actual">September 12, 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With PSA50 After 12 Weeks of Treatment</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Values for Testosterone</measure>
    <time_frame>Baseline, Cycle 1 Day 8 and Cycle 2 Day 1</time_frame>
    <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)</measure>
    <time_frame>Baseline, Cycle 1 Day 8 and Cycle 2 Day 1</time_frame>
    <description>Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Values for Adrenocorticotropic Hormone (ACTH)</measure>
    <time_frame>Baseline, Cycle 1 Day 8 and Cycle 2 Day 1</time_frame>
    <description>Serum ACTH was measured by immunometric assay at the central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Values for Corticosterone</measure>
    <time_frame>Baseline, Cycle 1 Day 8 and Cycle 2 Day 1</time_frame>
    <description>Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Values for Cortisol</measure>
    <time_frame>Baseline, Cycle 1 Day 8 and Cycle 2 Day 1</time_frame>
    <description>Serum Cortisol was measured by immunometric assay at the central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Values for Prostate-Specific Antigen (PSA)</measure>
    <time_frame>Baseline and Cycle 2 Day 1</time_frame>
    <description>Serum PSA was measured at the central laboratory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite</measure>
    <time_frame>Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
    <description>Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite</measure>
    <time_frame>Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
    <description>AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite</measure>
    <time_frame>Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
    <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite</measure>
    <time_frame>Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
    <description>Cumulative amount of urine excreted time 0 to 24 hour.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite</measure>
    <time_frame>Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
    <description>Maximum observed steady-state plasma concentration during a dosing interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite</measure>
    <time_frame>Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
    <description>Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite</measure>
    <time_frame>Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
    <description>Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rac: Accumulation Index for Orteronel and M-I Metabolite</measure>
    <time_frame>Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
    <description>Rac was calculated as the ratio of AUCtau to AUC12hr.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite</measure>
    <time_frame>Cycle 1 Day 8 Predose</time_frame>
    <description>Observed predose plasma concentration at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years</time_frame>
    <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Placebo + Orteronel 200 mg (Japan)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orteronel 200 mg (Japan)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Orteronel 300 mg (Japan)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orteronel 300 mg (Japan)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Orteronel 200 mg (Ex-Japan)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years.&#xD;
Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orteronel 200 mg (Ex-Japan)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Orteronel 400 mg (Ex-Japan)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orteronel 400 mg (Ex-Japan)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Orteronel</intervention_name>
    <description>Orteronel tablets</description>
    <arm_group_label>Orteronel 200 mg (Ex-Japan)</arm_group_label>
    <arm_group_label>Orteronel 200 mg (Japan)</arm_group_label>
    <arm_group_label>Orteronel 300 mg (Japan)</arm_group_label>
    <arm_group_label>Orteronel 400 mg (Ex-Japan)</arm_group_label>
    <arm_group_label>Placebo + Orteronel 200 mg (Ex-Japan)</arm_group_label>
    <arm_group_label>Placebo + Orteronel 200 mg (Japan)</arm_group_label>
    <arm_group_label>Placebo + Orteronel 300 mg (Japan)</arm_group_label>
    <arm_group_label>Placebo + Orteronel 400 mg (Ex-Japan)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Orteronel Placebo</intervention_name>
    <description>Orteronel placebo-matching tablets</description>
    <arm_group_label>Placebo + Orteronel 200 mg (Japan)</arm_group_label>
    <arm_group_label>Placebo + Orteronel 300 mg (Japan)</arm_group_label>
    <arm_group_label>Placebo + Orteronel 400 mg (Ex-Japan)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Prednisone 5 mg</description>
    <arm_group_label>Orteronel 200 mg (Ex-Japan)</arm_group_label>
    <arm_group_label>Orteronel 200 mg (Japan)</arm_group_label>
    <arm_group_label>Orteronel 300 mg (Japan)</arm_group_label>
    <arm_group_label>Orteronel 400 mg (Ex-Japan)</arm_group_label>
    <arm_group_label>Placebo + Orteronel 200 mg (Japan)</arm_group_label>
    <arm_group_label>Placebo + Orteronel 300 mg (Japan)</arm_group_label>
    <arm_group_label>Placebo + Orteronel 400 mg (Ex-Japan)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male participants 18 years or older&#xD;
&#xD;
          -  Voluntary written consent must be given before performance of any study-related&#xD;
             procedure not part of standard medical care, with the understanding that consent may&#xD;
             be withdrawn by the patient at any time without prejudice to future medical care&#xD;
&#xD;
          -  Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma&#xD;
&#xD;
          -  Prior surgical castration or concurrent use of an agent for medical castration [e.g.&#xD;
             Gonadotropin-releasing hormone (GnRH) analogue]&#xD;
&#xD;
          -  Prostate-Specific Antigen (PSA) ≥ 2 ng/mL at screening&#xD;
&#xD;
          -  Progressive disease based on PSA and/or radiographic criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior therapy with orteronel, ketoconazole, aminoglutethimide, or abiraterone.&#xD;
&#xD;
          -  Known hypersensitivity to compounds related to orteronel, orteronel excipients,&#xD;
             prednisone (or commercially available equivalent), or GnRH analogue.&#xD;
&#xD;
          -  All antiandrogen therapy (including bicalutamide) is excluded within 4 weeks before&#xD;
             the first dose of study drug. Any other therapies for prostate cancer, other than GnRH&#xD;
             analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol),&#xD;
             or 5- alpha reductase inhibitors (e.g., finasteride or dutasteride), must be&#xD;
             discontinued 2 weeks before the first dose of study drug.&#xD;
&#xD;
          -  Continuous daily use of oral prednisone (or commercially available equivalent), oral&#xD;
             dexamethasone, or other systemic corticosteroids for more than 2 weeks within the 3&#xD;
             months before screening (inhaled, nasal, and local steroids [e.g., joint injection]&#xD;
             are allowed).&#xD;
&#xD;
          -  Prior chemotherapy for prostate cancer, with the exception of neoadjuvant/adjuvant&#xD;
             therapy as part of initial primary treatment for local disease that was completed 2 or&#xD;
             more years before screening.&#xD;
&#xD;
        Please note that there are additional inclusion and exclusion criteria. The study center&#xD;
        will determine if you meet all of the criteria.&#xD;
&#xD;
        Site personnel will explain the trial in detail and answer any question you may have if you&#xD;
        do qualify for the study. You can then decide whether or not you wish to participate. If&#xD;
        you do not qualify for the trial, site personnel will explain the reasons.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Millennium Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology Cancer Center, PC</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <results_first_submitted>January 21, 2018</results_first_submitted>
  <results_first_submitted_qc>February 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 20, 2018</results_first_posted>
  <disposition_first_submitted>March 28, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>March 28, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">April 29, 2016</disposition_first_posted>
  <last_update_submitted>February 19, 2018</last_update_submitted>
  <last_update_submitted_qc>February 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>castrate resistant prostate cancer,</keyword>
  <keyword>CRPC,</keyword>
  <keyword>orteronel,</keyword>
  <keyword>TAK-700</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>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 43 investigative sites in Japan, United States, Greece, Australia, Netherlands, Ireland and United Kingdom from 20 August 2012 to 01 September 2016.</recruitment_details>
      <pre_assignment_details>Male participants with a diagnosis of adenocarcinoma of the prostate were enrolled in the study. In Japan, participants were randomized to 200 mg orteronel, Placebo, 300 mg orteronel, or Placebo, BID, in a ratio of 2:1:2:1; ex-Japan participants were randomized to 200 mg orteronel, Placebo, 400 mg orteronel, or Placebo, BID, in a ratio of 2:1:2:1.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo + Orteronel 200 mg (Japan)</title>
          <description>Orteronel placebo-matching tablets or Orteronel 200 mg, tablets, orally, twice daily (BID) in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily continuously throughout the study.</description>
        </group>
        <group group_id="P2">
          <title>Placebo + Orteronel 300 mg (Japan)</title>
          <description>Orteronel placebo-matching tablets or Orteronel 300 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="P3">
          <title>Placebo + Orteronel 200 mg (Ex-Japan)</title>
          <description>Orteronel placebo-matching tablets, or Orteronel 200 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="P4">
          <title>Placebo + Orteronel 400 mg (Ex-Japan)</title>
          <description>Orteronel placebo-matching tablets, or Orteronel 400 mg, tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="36"/>
                <participants group_id="P4" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="36"/>
                <participants group_id="P4" count="36"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Symptomatic Deterioration</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unsatisfactory Therapeutic Response</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not Specified</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data for baseline characteristics has been summarized as per the treatment received in Cycle 1.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo + Orteronel 200 mg (Japan)</title>
          <description>Orteronel placebo-matching tablets, orally, twice daily (BID) in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily continuously throughout the study.</description>
        </group>
        <group group_id="B2">
          <title>Orteronel 200 mg (Japan)</title>
          <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="B3">
          <title>Placebo + Orteronel 300 mg (Japan)</title>
          <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="B4">
          <title>Orteronel 300 mg (Japan)</title>
          <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="B5">
          <title>Placebo + Orteronel 200 mg (Ex-Japan)</title>
          <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="B6">
          <title>Orteronel 200 mg (Ex-Japan)</title>
          <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="B7">
          <title>Placebo + Orteronel 400 mg (Ex-Japan)</title>
          <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="B8">
          <title>Orteronel 400 mg (Ex-Japan)</title>
          <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="B9">
          <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="11"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="22"/>
            <count group_id="B5" value="11"/>
            <count group_id="B6" value="25"/>
            <count group_id="B7" value="12"/>
            <count group_id="B8" value="24"/>
            <count group_id="B9" value="137"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.1" lower_limit="62" upper_limit="84"/>
                    <measurement group_id="B2" value="68.5" lower_limit="52" upper_limit="82"/>
                    <measurement group_id="B3" value="70.1" lower_limit="59" upper_limit="76"/>
                    <measurement group_id="B4" value="71.5" lower_limit="51" upper_limit="85"/>
                    <measurement group_id="B5" value="69.6" lower_limit="51" upper_limit="85"/>
                    <measurement group_id="B6" value="69.9" lower_limit="55" upper_limit="84"/>
                    <measurement group_id="B7" value="73.3" lower_limit="60" upper_limit="84"/>
                    <measurement group_id="B8" value="69.4" lower_limit="49" upper_limit="88"/>
                    <measurement group_id="B9" value="70.6" lower_limit="49" upper_limit="88"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="25"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="24"/>
                    <measurement group_id="B9" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="25"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="23"/>
                    <measurement group_id="B9" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="25"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="23"/>
                    <measurement group_id="B9" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - Japanese</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greece</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ireland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="10"/>
                    <measurement group_id="B9" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="161.94" lower_limit="153.0" upper_limit="168.2"/>
                    <measurement group_id="B2" value="167.10" lower_limit="154.0" upper_limit="177.5"/>
                    <measurement group_id="B3" value="163.92" lower_limit="156.6" upper_limit="170.7"/>
                    <measurement group_id="B4" value="164.71" lower_limit="151.0" upper_limit="174.0"/>
                    <measurement group_id="B5" value="170.41" lower_limit="157.0" upper_limit="184.7"/>
                    <measurement group_id="B6" value="174.79" lower_limit="162.0" upper_limit="186.0"/>
                    <measurement group_id="B7" value="176.70" lower_limit="165.0" upper_limit="185.4"/>
                    <measurement group_id="B8" value="174.74" lower_limit="162.0" upper_limit="189.0"/>
                    <measurement group_id="B9" value="169.29" lower_limit="151.0" upper_limit="189.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.82" lower_limit="55.1" upper_limit="82.4"/>
                    <measurement group_id="B2" value="70.32" lower_limit="47.5" upper_limit="85.2"/>
                    <measurement group_id="B3" value="65.75" lower_limit="55.5" upper_limit="76.0"/>
                    <measurement group_id="B4" value="64.49" lower_limit="44.7" upper_limit="87.1"/>
                    <measurement group_id="B5" value="87.34" lower_limit="67.0" upper_limit="113.0"/>
                    <measurement group_id="B6" value="90.39" lower_limit="64.0" upper_limit="130.7"/>
                    <measurement group_id="B7" value="88.23" lower_limit="64.9" upper_limit="114.1"/>
                    <measurement group_id="B8" value="89.85" lower_limit="63.0" upper_limit="134.6"/>
                    <measurement group_id="B9" value="77.77" lower_limit="44.7" upper_limit="134.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.05" lower_limit="20.6" upper_limit="30.4"/>
                    <measurement group_id="B2" value="25.21" lower_limit="17.8" upper_limit="31.2"/>
                    <measurement group_id="B3" value="24.43" lower_limit="21.1" upper_limit="28.7"/>
                    <measurement group_id="B4" value="23.73" lower_limit="16.7" upper_limit="32.0"/>
                    <measurement group_id="B5" value="29.85" lower_limit="23.8" upper_limit="37.8"/>
                    <measurement group_id="B6" value="29.61" lower_limit="22.1" upper_limit="40.3"/>
                    <measurement group_id="B7" value="28.37" lower_limit="18.9" upper_limit="39.9"/>
                    <measurement group_id="B8" value="29.40" lower_limit="22.9" upper_limit="40.2"/>
                    <measurement group_id="B9" value="26.96" lower_limit="16.7" upper_limit="40.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan</title>
        <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
        <time_frame>Baseline and Week 4</time_frame>
        <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan</title>
          <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
          <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.0" lower_limit="63.7" upper_limit="97.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="84.6" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1078</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan</title>
        <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
        <time_frame>Baseline and Week 4</time_frame>
        <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Ex-Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan</title>
          <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
          <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.0" lower_limit="26.8" upper_limit="69.4"/>
                    <measurement group_id="O2" value="79.0" lower_limit="57.8" upper_limit="92.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0355</p_value>
            <method>Fisher Exact</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.145</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9895</ci_lower_limit>
            <ci_upper_limit>18.7606</ci_upper_limit>
            <estimate_desc>Odds ratio &gt;1 favors orteronel.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment</title>
        <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
        <time_frame>Baseline and Week 4</time_frame>
        <population>Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Ex-Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O5">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O6">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment</title>
          <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
          <population>Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-87.666" spread="10.4250"/>
                    <measurement group_id="O2" value="-97.245" spread="1.2548"/>
                    <measurement group_id="O3" value="-96.812" spread="2.7055"/>
                    <measurement group_id="O4" value="-63.702" spread="43.3941"/>
                    <measurement group_id="O5" value="-86.268" spread="37.2015"/>
                    <measurement group_id="O6" value="-53.954" spread="118.8050"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment</title>
        <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment</title>
          <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
          <population>Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-95.804" spread="5.3367"/>
                    <measurement group_id="O2" value="-95.703" spread="5.7468"/>
                    <measurement group_id="O3" value="-91.311" spread="17.5217"/>
                    <measurement group_id="O4" value="-14.442" spread="406.3116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment</title>
        <description>A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.</description>
        <time_frame>Baseline and Week 4</time_frame>
        <population>Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Ex-Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O5">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O6">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment</title>
          <description>A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.</description>
          <population>Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.0" lower_limit="25.7" upper_limit="70.2"/>
                    <measurement group_id="O2" value="50.0" lower_limit="28.2" upper_limit="71.8"/>
                    <measurement group_id="O3" value="41.0" lower_limit="20.7" upper_limit="63.6"/>
                    <measurement group_id="O4" value="17.0" lower_limit="5.0" upper_limit="38.8"/>
                    <measurement group_id="O5" value="48.0" lower_limit="27.8" upper_limit="68.7"/>
                    <measurement group_id="O6" value="46.0" lower_limit="25.6" upper_limit="67.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With PSA50 After 12 Weeks of Treatment</title>
        <description>A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.</description>
        <time_frame>Baseline and Week 12</time_frame>
        <population>Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With PSA50 After 12 Weeks of Treatment</title>
          <description>A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.</description>
          <population>Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="36"/>
                <count group_id="O4" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.0" lower_limit="36.4" upper_limit="71.9"/>
                    <measurement group_id="O2" value="47.0" lower_limit="29.1" upper_limit="65.3"/>
                    <measurement group_id="O3" value="56.0" lower_limit="38.1" upper_limit="72.1"/>
                    <measurement group_id="O4" value="44.0" lower_limit="27.9" upper_limit="61.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Values for Testosterone</title>
        <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
        <time_frame>Baseline, Cycle 1 Day 8 and Cycle 2 Day 1</time_frame>
        <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Ex-Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O5">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O6">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Values for Testosterone</title>
          <description>Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.</description>
          <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.749" spread="3.8460"/>
                    <measurement group_id="O2" value="9.079" spread="4.4581"/>
                    <measurement group_id="O3" value="10.148" spread="4.6504"/>
                    <measurement group_id="O4" value="9.173" spread="5.6123"/>
                    <measurement group_id="O5" value="9.263" spread="5.6572"/>
                    <measurement group_id="O6" value="14.588" spread="13.9833"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="19"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.957" spread="2.2843"/>
                    <measurement group_id="O2" value="0.213" spread="0.0449"/>
                    <measurement group_id="O3" value="0.251" spread="0.1727"/>
                    <measurement group_id="O4" value="3.509" spread="4.3471"/>
                    <measurement group_id="O5" value="0.345" spread="0.2770"/>
                    <measurement group_id="O6" value="6.658" spread="20.4347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.096" spread="0.7751"/>
                    <measurement group_id="O2" value="0.203" spread="0.0145"/>
                    <measurement group_id="O3" value="0.270" spread="0.2311"/>
                    <measurement group_id="O4" value="3.095" spread="3.7254"/>
                    <measurement group_id="O5" value="0.266" spread="0.1837"/>
                    <measurement group_id="O6" value="11.720" spread="45.1753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)</title>
        <description>Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.</description>
        <time_frame>Baseline, Cycle 1 Day 8 and Cycle 2 Day 1</time_frame>
        <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Ex-Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O5">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O6">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)</title>
          <description>Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.</description>
          <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1928.0" spread="1306.59"/>
                    <measurement group_id="O2" value="2529.0" spread="1309.39"/>
                    <measurement group_id="O3" value="2340.9" spread="1606.36"/>
                    <measurement group_id="O4" value="2601.7" spread="3009.41"/>
                    <measurement group_id="O5" value="1783.0" spread="1554.76"/>
                    <measurement group_id="O6" value="2155.7" spread="1591.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="414.9" spread="392.63"/>
                    <measurement group_id="O2" value="63.4" spread="55.11"/>
                    <measurement group_id="O3" value="71.8" spread="80.23"/>
                    <measurement group_id="O4" value="973.8" spread="1677.95"/>
                    <measurement group_id="O5" value="116.9" spread="161.01"/>
                    <measurement group_id="O6" value="226.6" spread="328.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="22"/>
                    <count group_id="O6" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="268.9" spread="357.32"/>
                    <measurement group_id="O2" value="14.5" spread="21.83"/>
                    <measurement group_id="O3" value="36.3" spread="123.48"/>
                    <measurement group_id="O4" value="815.7" spread="1918.88"/>
                    <measurement group_id="O5" value="21.5" spread="25.68"/>
                    <measurement group_id="O6" value="180.6" spread="527.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Values for Adrenocorticotropic Hormone (ACTH)</title>
        <description>Serum ACTH was measured by immunometric assay at the central laboratory.</description>
        <time_frame>Baseline, Cycle 1 Day 8 and Cycle 2 Day 1</time_frame>
        <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Ex-Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O5">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O6">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Values for Adrenocorticotropic Hormone (ACTH)</title>
          <description>Serum ACTH was measured by immunometric assay at the central laboratory.</description>
          <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
          <units>pmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="1.66"/>
                    <measurement group_id="O2" value="5.5" spread="2.54"/>
                    <measurement group_id="O3" value="8.3" spread="4.98"/>
                    <measurement group_id="O4" value="4.7" spread="2.06"/>
                    <measurement group_id="O5" value="6.0" spread="4.05"/>
                    <measurement group_id="O6" value="6.4" spread="4.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="2.68"/>
                    <measurement group_id="O2" value="2.3" spread="1.55"/>
                    <measurement group_id="O3" value="3.0" spread="2.70"/>
                    <measurement group_id="O4" value="3.1" spread="2.62"/>
                    <measurement group_id="O5" value="3.8" spread="3.04"/>
                    <measurement group_id="O6" value="3.2" spread="2.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="24"/>
                    <count group_id="O6" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.19"/>
                    <measurement group_id="O2" value="1.7" spread="1.08"/>
                    <measurement group_id="O3" value="2.7" spread="2.17"/>
                    <measurement group_id="O4" value="3.0" spread="1.73"/>
                    <measurement group_id="O5" value="3.7" spread="4.38"/>
                    <measurement group_id="O6" value="3.6" spread="2.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Values for Corticosterone</title>
        <description>Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.</description>
        <time_frame>Baseline, Cycle 1 Day 8 and Cycle 2 Day 1</time_frame>
        <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Ex-Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O5">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O6">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Values for Corticosterone</title>
          <description>Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.</description>
          <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.946" spread="3.4433"/>
                    <measurement group_id="O2" value="6.515" spread="4.8246"/>
                    <measurement group_id="O3" value="7.768" spread="6.8625"/>
                    <measurement group_id="O4" value="6.317" spread="4.1467"/>
                    <measurement group_id="O5" value="10.030" spread="7.7341"/>
                    <measurement group_id="O6" value="17.975" spread="35.0695"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.530" spread="1.6404"/>
                    <measurement group_id="O2" value="11.067" spread="14.4220"/>
                    <measurement group_id="O3" value="9.709" spread="13.4538"/>
                    <measurement group_id="O4" value="5.598" spread="7.1366"/>
                    <measurement group_id="O5" value="48.668" spread="66.3904"/>
                    <measurement group_id="O6" value="60.301" spread="77.5434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="23"/>
                    <count group_id="O6" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.758" spread="0.5108"/>
                    <measurement group_id="O2" value="11.108" spread="9.0708"/>
                    <measurement group_id="O3" value="14.654" spread="9.2064"/>
                    <measurement group_id="O4" value="4.321" spread="6.4063"/>
                    <measurement group_id="O5" value="29.929" spread="35.5565"/>
                    <measurement group_id="O6" value="47.204" spread="53.4566"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Values for Cortisol</title>
        <description>Serum Cortisol was measured by immunometric assay at the central laboratory.</description>
        <time_frame>Baseline, Cycle 1 Day 8 and Cycle 2 Day 1</time_frame>
        <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Ex-Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O5">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O6">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Values for Cortisol</title>
          <description>Serum Cortisol was measured by immunometric assay at the central laboratory.</description>
          <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="366.5" spread="116.69"/>
                    <measurement group_id="O2" value="371.3" spread="119.38"/>
                    <measurement group_id="O3" value="383.4" spread="125.98"/>
                    <measurement group_id="O4" value="384.8" spread="117.14"/>
                    <measurement group_id="O5" value="449.0" spread="131.54"/>
                    <measurement group_id="O6" value="446.8" spread="193.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="24"/>
                    <count group_id="O6" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.3" spread="46.16"/>
                    <measurement group_id="O2" value="49.5" spread="25.53"/>
                    <measurement group_id="O3" value="55.5" spread="55.97"/>
                    <measurement group_id="O4" value="175.8" spread="107.82"/>
                    <measurement group_id="O5" value="100.9" spread="87.38"/>
                    <measurement group_id="O6" value="122.0" spread="88.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="24"/>
                    <count group_id="O6" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.9" spread="24.92"/>
                    <measurement group_id="O2" value="49.2" spread="21.71"/>
                    <measurement group_id="O3" value="54.3" spread="39.93"/>
                    <measurement group_id="O4" value="149.6" spread="122.91"/>
                    <measurement group_id="O5" value="97.2" spread="85.66"/>
                    <measurement group_id="O6" value="109.1" spread="83.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Values for Prostate-Specific Antigen (PSA)</title>
        <description>Serum PSA was measured at the central laboratory.</description>
        <time_frame>Baseline and Cycle 2 Day 1</time_frame>
        <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Ex-Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O5">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O6">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Values for Prostate-Specific Antigen (PSA)</title>
          <description>Serum PSA was measured at the central laboratory.</description>
          <population>Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.588" spread="48.9413"/>
                    <measurement group_id="O2" value="27.227" spread="24.8821"/>
                    <measurement group_id="O3" value="97.504" spread="293.9496"/>
                    <measurement group_id="O4" value="133.238" spread="189.9345"/>
                    <measurement group_id="O5" value="165.992" spread="368.5016"/>
                    <measurement group_id="O6" value="100.237" spread="210.5675"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="24"/>
                    <count group_id="O6" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.325" spread="46.9725"/>
                    <measurement group_id="O2" value="18.005" spread="16.9858"/>
                    <measurement group_id="O3" value="38.892" spread="95.0124"/>
                    <measurement group_id="O4" value="152.940" spread="261.9735"/>
                    <measurement group_id="O5" value="117.257" spread="286.1870"/>
                    <measurement group_id="O6" value="56.437" spread="97.1621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite</title>
        <description>Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.</description>
        <time_frame>Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
        <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite</title>
          <description>Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.</description>
          <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Orteronel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1520" spread="23.9"/>
                    <measurement group_id="O2" value="2210" spread="33.9"/>
                    <measurement group_id="O3" value="1300" spread="59.7"/>
                    <measurement group_id="O4" value="1610" spread="50.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orteronel Metabolite M-I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="272" spread="33.1"/>
                    <measurement group_id="O2" value="422" spread="37.0"/>
                    <measurement group_id="O3" value="199" spread="61.9"/>
                    <measurement group_id="O4" value="261" spread="47.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite</title>
        <description>AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study.</description>
        <time_frame>Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
        <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite</title>
          <description>AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study.</description>
          <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
          <units>h*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Orteronel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8810" spread="16.4"/>
                    <measurement group_id="O2" value="12800" spread="31.2"/>
                    <measurement group_id="O3" value="7830" spread="51.1"/>
                    <measurement group_id="O4" value="10200" spread="41.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orteronel Metabolite M-I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2130" spread="28.3"/>
                    <measurement group_id="O2" value="3290" spread="33.8"/>
                    <measurement group_id="O3" value="1570" spread="65.5"/>
                    <measurement group_id="O4" value="2080" spread="44.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite</title>
        <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.</description>
        <time_frame>Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
        <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite</title>
          <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.</description>
          <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Orteronel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.97" lower_limit="1.00" upper_limit="5.10"/>
                    <measurement group_id="O2" value="2.43" lower_limit="1.00" upper_limit="4.97"/>
                    <measurement group_id="O3" value="2.00" lower_limit="0.500" upper_limit="7.93"/>
                    <measurement group_id="O4" value="1.92" lower_limit="0.500" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orteronel Metabolite M-I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" lower_limit="2.03" upper_limit="8.10"/>
                    <measurement group_id="O2" value="4.98" lower_limit="2.00" upper_limit="8.23"/>
                    <measurement group_id="O3" value="5.05" lower_limit="1.03" upper_limit="11.1"/>
                    <measurement group_id="O4" value="4.98" lower_limit="1.22" upper_limit="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite</title>
        <description>Cumulative amount of urine excreted time 0 to 24 hour.</description>
        <time_frame>Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
        <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite</title>
          <description>Cumulative amount of urine excreted time 0 to 24 hour.</description>
          <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
          <units>mg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Orteronel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115.0" spread="26.0"/>
                    <measurement group_id="O2" value="164.0" spread="26.2"/>
                    <measurement group_id="O3" value="95.3" spread="31.9"/>
                    <measurement group_id="O4" value="161.0" spread="41.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orteronel Metabolite M-I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.6" spread="31.5"/>
                    <measurement group_id="O2" value="62.5" spread="26.6"/>
                    <measurement group_id="O3" value="30.0" spread="40.1"/>
                    <measurement group_id="O4" value="52.8" spread="46.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite</title>
        <description>Maximum observed steady-state plasma concentration during a dosing interval.</description>
        <time_frame>Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
        <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite</title>
          <description>Maximum observed steady-state plasma concentration during a dosing interval.</description>
          <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Orteronel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2180" spread="22.4"/>
                    <measurement group_id="O2" value="3210" spread="31.5"/>
                    <measurement group_id="O3" value="1840" spread="37.1"/>
                    <measurement group_id="O4" value="3100" spread="45.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orteronel Metabolite M-I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="565" spread="32.4"/>
                    <measurement group_id="O2" value="864" spread="39.5"/>
                    <measurement group_id="O3" value="485" spread="75.4"/>
                    <measurement group_id="O4" value="761" spread="81.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite</title>
        <description>Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state.</description>
        <time_frame>Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
        <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite</title>
          <description>Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state.</description>
          <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
          <units>hours</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="22"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Orteronel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.05" lower_limit="1.00" upper_limit="5.08"/>
                    <measurement group_id="O2" value="2.96" lower_limit="1.00" upper_limit="5.17"/>
                    <measurement group_id="O3" value="2.00" lower_limit="0.550" upper_limit="5.17"/>
                    <measurement group_id="O4" value="1.98" lower_limit="0.500" upper_limit="3.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orteronel Metabolite M-I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.08" lower_limit="2.00" upper_limit="5.17"/>
                    <measurement group_id="O2" value="4.78" lower_limit="2.00" upper_limit="8.13"/>
                    <measurement group_id="O3" value="3.00" lower_limit="1.00" upper_limit="5.07"/>
                    <measurement group_id="O4" value="3.00" lower_limit="0" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite</title>
        <description>Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.</description>
        <time_frame>Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
        <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite</title>
          <description>Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.</description>
          <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
          <units>h*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Orteronel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13300" spread="20.4"/>
                    <measurement group_id="O2" value="20400" spread="36.1"/>
                    <measurement group_id="O3" value="12600" spread="36.2"/>
                    <measurement group_id="O4" value="20000" spread="55.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orteronel Metabolite M-I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4840" spread="35.0"/>
                    <measurement group_id="O2" value="7460" spread="46.3"/>
                    <measurement group_id="O3" value="4340" spread="69.4"/>
                    <measurement group_id="O4" value="6590" spread="78.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rac: Accumulation Index for Orteronel and M-I Metabolite</title>
        <description>Rac was calculated as the ratio of AUCtau to AUC12hr.</description>
        <time_frame>Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose</time_frame>
        <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Rac: Accumulation Index for Orteronel and M-I Metabolite</title>
          <description>Rac was calculated as the ratio of AUCtau to AUC12hr.</description>
          <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Orteronel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.51" spread="9.1"/>
                    <measurement group_id="O2" value="1.59" spread="46.6"/>
                    <measurement group_id="O3" value="1.62" spread="39.3"/>
                    <measurement group_id="O4" value="1.97" spread="90.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orteronel Metabolite M-I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.27" spread="17.5"/>
                    <measurement group_id="O2" value="2.26" spread="43.0"/>
                    <measurement group_id="O3" value="2.76" spread="45.0"/>
                    <measurement group_id="O4" value="3.17" spread="77.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite</title>
        <description>Observed predose plasma concentration at steady state.</description>
        <time_frame>Cycle 1 Day 8 Predose</time_frame>
        <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite</title>
          <description>Observed predose plasma concentration at steady state.</description>
          <population>Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Orteronel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="710" spread="28.1"/>
                    <measurement group_id="O2" value="1060" spread="63.7"/>
                    <measurement group_id="O3" value="807" spread="45.4"/>
                    <measurement group_id="O4" value="899" spread="59.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orteronel Metbolite M-I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="291" spread="47.1"/>
                    <measurement group_id="O2" value="444" spread="66.7"/>
                    <measurement group_id="O3" value="314" spread="68.6"/>
                    <measurement group_id="O4" value="417" spread="58.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.</description>
        <time_frame>From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years</time_frame>
        <population>Safety Population included all randomized participants who received at least one dose of study drug. Adverse events are summarized as per the treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O2">
            <title>Orteronel 200 mg (Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan and ex-Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O3">
            <title>Orteronel 300 mg (Japan)</title>
            <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O4">
            <title>Placebo (Ex-Japan)</title>
            <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O5">
            <title>Orteronel 200 mg (Ex-Japan)</title>
            <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
          <group group_id="O6">
            <title>Orteronel 400 mg (Ex-Japan)</title>
            <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.</description>
          <population>Safety Population included all randomized participants who received at least one dose of study drug. Adverse events are summarized as per the treatment received.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="32"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="36"/>
                    <measurement group_id="O6" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="16"/>
                    <measurement group_id="O6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years.</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Adverse events were summarized as per the treatment received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days). Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="E2">
          <title>Orteronel 200 mg (Japan)</title>
          <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="E3">
          <title>Orteronel 300 mg (Japan)</title>
          <description>Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="E4">
          <title>Orteronel 200 mg (Ex-Japan)</title>
          <description>Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
        <group group_id="E5">
          <title>Orteronel 400mg (Ex-Japan)</title>
          <description>Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (16.0)</default_vocab>
        <default_assessment>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="10" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="36"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Coronary Artery Stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Myocardial Ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Large Intestine Polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Vomitting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Angiodysplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Bile Duct Stone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Device Related Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Lumbar Vertebral Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Spinal Compression Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Thoracic Vertebral Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Facial Bones Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Pancreatic enzymes increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rotator Cuff Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Spinal Ligament Ossification</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Lumbar Spinal Stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pathological Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Renal neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Lung Neoplasm Malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pancreatic Carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Metastatic Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Altered State Of Consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Parkinsonism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Renal Colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis exfoliative</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (16.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="44"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="36"/>
                <counts group_id="E5" subjects_affected="36" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Increased tendency to bruise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Cushingoid</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="44"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="32"/>
                <counts group_id="E4" events="13" subjects_affected="10" subjects_at_risk="36"/>
                <counts group_id="E5" events="13" subjects_affected="12" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="44"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E4" events="30" subjects_affected="15" subjects_at_risk="36"/>
                <counts group_id="E5" events="16" subjects_affected="13" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="7" subjects_at_risk="44"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E3" events="10" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E4" events="17" subjects_affected="13" subjects_at_risk="36"/>
                <counts group_id="E5" events="16" subjects_affected="12" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="11" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" events="12" subjects_affected="9" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="7" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Chronic Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="22" subjects_affected="19" subjects_at_risk="36"/>
                <counts group_id="E5" events="17" subjects_affected="15" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="36"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Face Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="44"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E3" events="13" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Upper respiratory trat infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="6" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="8" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" events="8" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="36" subjects_affected="19" subjects_at_risk="44"/>
                <counts group_id="E2" events="46" subjects_affected="25" subjects_at_risk="33"/>
                <counts group_id="E3" events="32" subjects_affected="19" subjects_at_risk="32"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="36"/>
                <counts group_id="E5" events="9" subjects_affected="7" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="21" subjects_affected="16" subjects_at_risk="44"/>
                <counts group_id="E2" events="35" subjects_affected="21" subjects_at_risk="33"/>
                <counts group_id="E3" events="27" subjects_affected="19" subjects_at_risk="32"/>
                <counts group_id="E4" events="7" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E5" events="10" subjects_affected="6" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="44"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E3" events="11" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="44"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E3" events="11" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="44"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E3" events="14" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="9" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="44"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="8" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Glycosylated haemoglobin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="44"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="33"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="8" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="36"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="16" subjects_affected="11" subjects_at_risk="44"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E4" events="11" subjects_affected="8" subjects_at_risk="36"/>
                <counts group_id="E5" events="22" subjects_affected="12" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="36"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Metastatic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="36"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="36"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Haemorrhage subcutaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Skin atrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="44"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="36"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="44"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="44"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director, Clinical Science</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.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/NCT01666314
org study id: C21013
secondary id: 2012-001539-30
secondary id: U1111-1179-5750
nct id: NCT01666314
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the
      pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly
      with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate Cancer
The drug being tested in this study is called orteronel. Orteronel is being tested to treat
      adult males who have adenocarcinoma of the prostate. This study will look at the
      pharmacokinetics (how the drug moves through the body) and pharmacodynamics (how the drug
      effects the body) in people who take orteronel in addition to prednisone.

      The study will enroll approximately 144 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the eight treatment groups (4 in Japan, 4 in
      Ex-Japan) which will remain undisclosed to the participant and study doctor during the study
      (unless there is an urgent medical need).

      In Japan:

      Participants were randomized in a ratio of 2:1:2:1

        -  200 mg orteronel or Placebo-matching orteronel [(dummy inactive pill) - this is a tablet
           that looks like the study drug but has no active ingredient] twice daily (BID) +
           prednisone

        -  300 mg orteronel, or Placebo-matching orteronel, BID + prednisone Ex-Japan Participants
           were randomized in a ratio of 2:1:2:1

        -  200 mg orteronel or Placebo-matching orteronel, BID in Cycle 1 + prednisone

        -  400 mg orteronel, or Placebo-matching orteronel ,BID in Cycle 1 + Prednisone

      Participants initially randomized to placebo received 4 weeks of placebo and then 12 weeks of
      active treatment with orteronel then entered a follow-up period treatment period.
      Participants initially randomized to orteronel received 16 weeks of treatment then entered a
      follow-up treatment period.

      This multi-centre trial will be conducted worldwide. The overall time to participate in this
      study is approximately 3.2 years. Participants will make multiple visits to the clinic and a
      final visit 30 to 40 days after receiving their last dose of study drug for a follow-up
      assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan
time frame: Baseline and Week 4
description: Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
measure: Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan
time frame: Baseline and Week 4
description: Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
measure: Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment
time frame: Baseline and Week 4
description: Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
measure: Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment
time frame: Baseline and Week 12
description: Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
measure: Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment
time frame: Baseline and Week 4
description: A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
measure: Percentage of Participants With PSA50 After 12 Weeks of Treatment
time frame: Baseline and Week 12
description: A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.
measure: Absolute Values for Testosterone
time frame: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
description: Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.
measure: Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)
time frame: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
description: Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.
measure: Absolute Values for Adrenocorticotropic Hormone (ACTH)
time frame: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
description: Serum ACTH was measured by immunometric assay at the central laboratory.
measure: Absolute Values for Corticosterone
time frame: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
description: Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.
measure: Absolute Values for Cortisol
time frame: Baseline, Cycle 1 Day 8 and Cycle 2 Day 1
description: Serum Cortisol was measured by immunometric assay at the central laboratory.
measure: Absolute Values for Prostate-Specific Antigen (PSA)
time frame: Baseline and Cycle 2 Day 1
description: Serum PSA was measured at the central laboratory.
measure: Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite
time frame: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
description: Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
measure: AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite
time frame: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
description: AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study.
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite
time frame: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
description: Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
measure: AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite
time frame: Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
description: Cumulative amount of urine excreted time 0 to 24 hour.
measure: Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite
time frame: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
description: Maximum observed steady-state plasma concentration during a dosing interval.
measure: Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite
time frame: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
description: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state.
measure: AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite
time frame: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
description: Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
measure: Rac: Accumulation Index for Orteronel and M-I Metabolite
time frame: Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose
description: Rac was calculated as the ratio of AUCtau to AUC12hr.
measure: Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite
time frame: Cycle 1 Day 8 Predose
description: Observed predose plasma concentration at steady state.
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years
description: An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
arm group label: Placebo + Orteronel 200 mg (Japan)
arm group type: Other
description: Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 (28 days) followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
arm group label: Orteronel 200 mg (Japan)
arm group type: Experimental
description: Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 3 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
arm group label: Placebo + Orteronel 300 mg (Japan)
arm group type: Other
description: Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
arm group label: Orteronel 300 mg (Japan)
arm group type: Experimental
description: Orteronel 300 mg, tablets, orally, twice daily in 28 day cycles in Japan for up to 2.8 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
arm group label: Placebo + Orteronel 200 mg (Ex-Japan)
arm group type: Other
description: Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 200 mg, tablets, orally, twice daily in 28 day cycles outside of Japan (Ex-Japan) for up to 3.1 years.
Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
arm group label: Orteronel 200 mg (Ex-Japan)
arm group type: Experimental
description: Orteronel 200 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
arm group label: Placebo + Orteronel 400 mg (Ex-Japan)
arm group type: Other
description: Orteronel placebo-matching tablets, orally, twice daily in Cycle 1 followed by orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
arm group label: Orteronel 400 mg (Ex-Japan)
arm group type: Experimental
description: Orteronel 400 mg, tablets, orally, twice daily in 28 day cycles Ex-Japan for up to 3.1 years. Study drug will be administered concomitantly with prednisone (or commercially available equivalent) 5 mg twice daily (BID) continuously throughout the study.
intervention type: Drug
intervention name: Orteronel
description: Orteronel tablets
arm group label: Orteronel 200 mg (Ex-Japan)
arm group label: Orteronel 200 mg (Japan)
arm group label: Orteronel 300 mg (Japan)
arm group label: Orteronel 400 mg (Ex-Japan)
arm group label: Placebo + Orteronel 200 mg (Ex-Japan)
arm group label: Placebo + Orteronel 200 mg (Japan)
arm group label: Placebo + Orteronel 300 mg (Japan)
arm group label: Placebo + Orteronel 400 mg (Ex-Japan)
intervention type: Drug
intervention name: Orteronel Placebo
description: Orteronel placebo-matching tablets
arm group label: Placebo + Orteronel 200 mg (Japan)
arm group label: Placebo + Orteronel 300 mg (Japan)
arm group label: Placebo + Orteronel 400 mg (Ex-Japan)
intervention type: Drug
intervention name: Prednisone
description: Prednisone 5 mg
arm group label: Orteronel 200 mg (Ex-Japan)
arm group label: Orteronel 200 mg (Japan)
arm group label: Orteronel 300 mg (Japan)
arm group label: Orteronel 400 mg (Ex-Japan)
arm group label: Placebo + Orteronel 200 mg (Japan)
arm group label: Placebo + Orteronel 300 mg (Japan)
arm group label: Placebo + Orteronel 400 mg (Ex-Japan)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Monitor
role: Study Director
affiliation: Millennium Pharmaceuticals, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prednisone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 